Timothy Hillard

Trainings & Qualifications (continued)

• Nasopharyngeal swabs: training by sponsor-provided videos and materials; Conducting the swabs for flu and allergy studies since 2003
• Electronic diaries: sponsor- and vendor-provided training since 2006
• Electronic consent: sponsor and vendor training since 2011
• Electronic source documents: sponsor and vendor training since 2014
• CSSR-S: sponsor, national training; certificate may be available since 2005
• Bristol Scales: sponsor training since 2009
• Incubation of samples: sponsor/vendor training; incubating for flu, pneumonia & other bacterial infection studies since 2009
• PK Icebaths: in-house training, sponsor & lab training since 2009
• PK Centrifuge: in-house training, sponsor/lab training since 2000
• Centrifuge: training by site, including cup size, RPMs, & calibrations since 2000
• EKG acquisition: site training per cardiologist; lead placement per sponsor recommendations; conducting since 2000
• EKG transmission: sponsor/vendor training; both computer/phone line since 2006
• CPR: BLS certificate since 2000
• Vitals: include temp, wt, ht, BP, HR; site training; manual/automatic BP; oral, temporal, auricle temp since 2000
• IATA: computer training; current certificate holder since 2000
• EDC Experience: sponsor training; includes Medidata Rave, InForm, Oracle, MedNet Solutions, Phase Forward, Forest since 2008
• IXRS: sponsor training; includes PPDI, Premier Research i360 IRT, Cenduit IRT, IMPALA, Almac Web IRT, ClinPhone RTSM, ClinPhone, Medpace, IRT plus/Trident since 2008
• GCP CITI: current certificate holder since 2009
• MiniMental: sponsor training/national training since 2005
• Questionnaires: sponsor/national training; includes PAC-QOL, PAC-SYM, Disease Severity, Disease QOL, Global Symptom Relief, Global Pain Relief, HADS, MIDAS, Treatment Satisfaction since 2009
• Cognitive testing: site, sponsor, national training since 2009
• Rapid Result Labs: include drug screening, nicotine, pregnancy, urine dip stick; sponsor, central lab specific, local lab, & site training since 2000
• PT INR: local lab training, sponsor training, central lab training, and site training since 2009
• ABI, TBI: sponsor and national training since 2009
• Lab Sample processing: sponsor, central lab specific, local lab, & site training since 2000
• Hamilton Rating Scale for Depression (HAM-D) & (SIGH-D) since 2006
• Montgomery Aspberg Depression Rating Scale (MADRS) since 2006
• Edinburgh Post Natal Depression Rating Scale (EPDS) since 2006
• Generalized Anxiety Disorder Scale (GAD) since 2001
• Patient Health Questionnaire (PHQ) since 2009
• Barkin Index of Maternal Functioning (BIMF) since 2010
• Health & Well Being (SF36) since 2009
• Health Resource Utilization Questionnaire (HRUQ) since 2011
• Structural Clinical Interview for DSM-1 Axis 1 Disorders (SCID-1) since 2011

Clinical Research

(The following is a listing of past 2 years to present. Further back available on request.)

• A phase II, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-week study with a 40 week, Active Controlled, Double-Blind Extension to evaluate the efficacy and safety of K-877 in adult patients with Fasting Triglyceride Levels > 500 mg/dL and
• A randomized, Double-Blind, Placebo-controlled, parallel-group study to evaluate the effect of long-term treatment with BELVIQ (lorcaaserin HCI) in the Incidence of major adverse cardiovascular events and conversion to Type 2 Diabetes Mellitus in Obese and overweight subjects with cardiovascular disease or multiple cardiovascular risk factors. TIMI 61
• A 12 week randomized, double-blind, placebo-controlled, parallel-group, dose ranging study with follow-up, evaluating the safety and efficacy of Varencline for smoking cessation in Healthy Adolescent Smokers. PFIZER TEEN SMOKING
• An open-label, long-term, safety study of Lasmiditan (200 mg and 100 mg) in the acute Treatment of Migraine. GLADIATOR COL-MIG-305
• A study of 3 doses (50 mg, 100 mg and 200 mg) compared to placebo in the acute treatment of migraine: A randomized, double-blind, placebo-controlled parallel group study. SPARTAN COL-MIG-302
• A randomized, double-blind, placebo-controlled event driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial patients with elevated hsCRP. CANTOS
• A Double-blind, Randomized, Placebo-controlled, Multicenter Study assessing the Impact of Additional LOL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination with Statin Therapy in Patients with Clinically Evident Cardiovascular Disease. Amgen
• A phase 3, open-label extension study of DS-5565 for a 52 week in pain associated with Fibromyalgia. FIBRO E312 & E310
• A randomized, open-label, parallel-group real world pragmatic trial to assess the clinical and health outcomes of Touejo compared to commercially available basal insulins for initiation of therapy in insulin naïve patients with uncontrolled type 2 diabetes mellitus. TOUJEO
• A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of SAR236553/REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an acute Coronary Syndrome. ODYSSEY
• An open label Phase II Multiple Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 followed by open label administration of SEL-037 in subjects with symptomatic Gout and elevated blood uric acid. SELECTA
• A Phase III multi-center, double-blind, randomized, placebo-controlled, parallel group evaluation of the efficacy, safety and tolerability of Bococizumab (PF 04950615), in reducing the occurrence of major cardiovascular events in high risk subjects. SPIRE
• A randomized, double-blind, event-driven, multicenter study comparing the efficacy and safety of Rivaroxaban with placebo for reducing the risk of death, myocardial infarction or stroke in subjects with heart failure and significant coronary artery disease following an episode of decompensated heart failure. RIVAROX3001 – COMMANDER
• A multinational, randomized, double-blind, placebo-controlled trial to evaluate the effect of Ticagrelor twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with Type 2 Diabetes Mellitus. THEMIS
• A Phase III study to evaluate the efficacy and safety of Elagolix in combination with Estradiol/Norethindrone acetate for the management of heavy menstrual bleeding associated with Uterine Fibroids in Premenopausal Women. ABBVIE
• A randomized, double-blind, placebo-controlled, event driven trial of weekly low-dose methotrexate (LDM) in the prevention of cardiovascular events among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome. CIRT
• A Phase III, double-blind, randomized, placebo-controlled study to evaluate the effects of Dalcetrapib on Cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial.
• A parallel-group, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of ALD403 administered intravenously in patients with frequent episodic migraines. ALDER MIGRAINE
• An open-label study of chronic use of BLI400 laxative in constipated adults. BLI400-303
• To assess warffarin management issues faced by atrial fibrillation in ambulatory settings. We will place a particular focus on evidence to support the future development of quality care measures to improve shared decision-making through the assessment of patient-centered risks, and the benefits of long term anticoagulation. ELITE
• Post Approval Registry (Corox, OTW, Endocardial, Left Ventricular Steriod Lead, Bipolar Post Approve Registry). CELESTIAL
• Registry (Long Term evaluation of the Linox Family ICD Leads Registry). GALAXY
• A 52 week, open label evaluation of the effects of sacubitril/valsartan (LCZ696) therapy on biomarkers, myocardial remodeling and patient – reported outcomes in heart failures with reduced left ventricular ejection fraction. PROVE-HF
• A multi-center, randomized, double-blind, parallel group, placebo-controlled study evaluating the efficacy, safety, and pharmacokinetics of SAGE 547-PPD-202 injection in the treatment of adult female subjects with severe postpartum depression and adult female subjects with moderate postpartum depression. SAGE 547-PPD-202
• A Phase III, randomized, open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (MONOFER) and iron sucrose in subjects with iron deficiency anemia and non-dialysis-dependent chronic kidney disease. CKD-04
• A phase III, randomized, open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (MONOFER) and iron sucrose in subjects with iron deficiency anemia who are intolerant or unresponsive to oral therapy or in whom the hemoglobin measurement in Investigator’s opinion were sufficiently low as to require repletion of iron stores to minimize the risk of receiving a blood transfusion. P-MONOFER-IDA-03
• A randomized, Double-Blind, Parallel-Group, Placebo and active controlled, multicenter phase 3 study to the efficacy and safety of Olokizumab in Subjects with moderately to severely active Rheumatoid Arthritis Inadequately controlled by Methortrexate therapy. CREDO 2
• A randomized, double-blind, parallel-group, placebo-controlled, multicenter, phase 3 study to the efficacy and safety of Olokizumab in Subjects with moderately to severely ACTIVE Rheumatoid Arthritis Inadequately controlled by tumor necrosis Factor Alpha (TNA-a) Inhibitor Therapy. CREDO 3
• A Multicenter, open-label, Phase 3 Study of the Safety and efficacy of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis. CREDO 4
• A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C) (the CIBS Study) Synergy II
• A Randomized, 12-SWeek, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess Safety and Efficacy of Plecanatide in Patients with Chronic Idiopathic Constipation. Synergy
• CANTOS
• A 24-Week, Double-Blind, Active-Controlled, Parallel Group trial to assess the superiority of Lingliptin and Metformin Compared to Linagliptin Monotherapy in Newly Diagnosed, Treatment-Naïve, Uncontrolled Type 2 Diabetes Mellitus Patients.
• Safety and Efficacy Evaluation of Topical AL60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa. Alcon
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer pain. Cubist
• A phase III, multicenter, randomized, double blind, placebo-controlled clinical trial to study the safety and Insulin-sparing efficacy of the addition of Sitaliptin in patients with Type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with Metformin. MK 260-00
• A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban versus (LMW) Heparin/Warfarin in Subjects with Symptomatic Deep-Vein Thrombosis and/or Pulmonary Embolism. Hokusai
• Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D). Alecardio
• The IMPACT of Biotronik Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with ICD and CRT-D Devices. Impact
• Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. Orbit
• An Observational Prospective Registry to Identify Demographic and Clinical Characteristics of Patients Hospitalized with Euvolemic and Hypervolemic Hyponatremia and Assess the Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization. Otsuka
• A multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin
  (Ezetimibe/Simvastatin tablet) vs Simvistatin monotherapy in high-risk subjects presenting with acute coronary syndrome (IMPROVED Reduction of Outcomes: Vytorin Efficacy International Trial – Improve It). Improve It PO: 4103
• A Phase III, Randomized, Double-Blind, Cross-over Trial of Apadenoson for the Detection of Myocardial perfusion, Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusiom Imaging (MPI). Aspect
• A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Cross-over Trial to Evaluate the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging. Gil103
• A Phase 3, Multicenter, Randomizes, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an inadequate Response to one or more TNF-A Inhibitors. LBCDV
• A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY212399 in Patients with Rheumatoid Arthritis (RA). LBCDP
• A randomized, double-blind, active-controlled study of canakinumab (ACZ885) pre-filled syringes or reconstituted lyophilizate versus triamcinolone acetonide for treating acut gouty arthritis flares in frequently flaring patients. No2361
• A Phase III, open-label, three-group parallel study to evaluate the efficacy and safety of Human Insulin Inhalation in Powder (HIIP) in patients with Type 2 Diabetes treated with Once-Daily Insulin Glargine. IDBA
• The Durability of a Twice-Daily Insulin Lispro Low Mixture compared to Once-Daily Insulin Glargine when added to existing oral therapy in patients with Type 2 Diabetes and inadequate Glycemic control. IOOV
• A Multi-center, Double-Blind, study of the efficacy and safety of Aripiprazole in combination with Lamotrigine in the long- term maintenance treatment of patients with Bipolar Disorder with a recent manic or mixed episode. CN138-392
• A Phase IV, randomized double-blind study to assess the Immune Reactivity of the Liquid and Lyophilized formulations of Palivizumab (MEDI-493, Synagis) in Children at high risk for the development of Serious RSV Disease, Med116
• Phase II, prospective, randomized, open-label study to evaluate the immune responses for Flumist compared with Trivalent Inactivated Vaccine (TIV) in children 12 to
• A Double-Blind, parallel, multi-center study of Axid (nizatidine) Oral Solution in the treatment of Gastroesophageal Reflux Disease (GERD) symptoms in infants age 30 days – 1 year. BLIAX001
• A Randomized, Double-Blind, Active and Placebo-controlled, parallel-group, Multicenter study to evaluate the efficacy and safety of multiple doses of CG5503 Immediate-Release Formulation in subjects awaiting Primary Joint Replacement surgery for End-stage Joint Disease, JJ
• A Phase IV, Multi-Center, Open-Label, safety and effectiveness study of Extended-Release Carbamazepine in the treatment of Mania in children and adolescents ages 10 – 17 years of age with Acute Mania or Mixed Bipolar Disorder 1. S311
• Immunogenicity and safety of a split, inactivated, trivalent influenza vaccine administered by intradermal route in comparison with intramuscular vaccination with standard Fluzone in healthy infants and young children, FID07
• A Multi-center, randomized, double-blind, parallel arm, 12-week study to evaluate the efficacy and safety of Ezetimibe 10mg when added to Atorvastatin 10mg versus Titration to Atorvastatin 20mg and to 40mg in elderly patients with Hypercholesterolemia at high risk for CHD. M112
• A Multi-center, randomized, double-blind, parallel-group, 12-week study to evaluate the efficacy and safety of MK-0524B (dosed as coadministered MK-0524A and Simvastatin tablets) versus Atorvastatin in patients with Mixed Hyperlipidemia. M024
• A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX®
  (ciprofloxacin 0.3% dexamtheasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Adults with Acute Bacterial Otitis Externa. Novum AOE
• A Randomized, Double-Blind, Placebo-Controlled, safety and efficacy study of Xyrem (sodium oxybate) in subjects with Fibromyalgia. Ja009
• A Long-term, open-label safety and efficacy study of Xyrem (sodium oxybate) in subjects with Fibromyalgia. Ja010
• An Immunogenicity, Safety, and Non-Interfence evaluation of Pediatric vaccines administered concomitantly with Menactra (Meningococcal Groups A, C, Y, and W-135) Polysaccharie Diphtheria Toxoid Conjugate vaccine to Healthy toddlers. MTA37
• A Multi-center, Double-Blind, Placebo-Controlled, Randomized, Parallel Group study to evaluate the clinical effect of Oral Montelukast versus Placebo in persistent Asthma which is also active during the Allergy Seasons in Pediatric Patients with Seasonal Aeroallergen Sensitivity. SNG583
• Efficacy and Safety of 2mg/day of M100907 on sleep maintenance insomnia with a sub-study of the effect of M100907 on stable Type 2 Diabetes Mellitus: a One-year, Multi-center, randomized, double-blind, placebo-controlled study. LTE6673
• A Phase III, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to study the Efficacy and Safety of MK-0431A in patients with Type 2 Diabetes Mellitus. M079
• An expanded Phase ½, randomized, double-blind, placebo-controlled, study to evaluate the safety, tolerability, immunogenicity and viral shedding of MEDI-560, a live, attenuated recombinant Parainfluenza Virus Type 3 (PIV3)
• Vaccine administered intranasally to healthy infants 1 to
• A 7-day, randomized, double-masked, parallel-group, Multi-center study to evaluate the safety and efficacy of Topical Gatifloxacin 0.3% Ophthalmic Solution compared with Topical Moxifloxacin 0.5% Ophthalmic Solution for the treatment of Presumed Bacterial Conjunctivitis in subjects from birth to 31 days of age. A003
• A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN-400 or Naproxen in Subjects Who are at Risk for Developing NSAID-associated ulcers. P400-30
• A 6-Month, Randomized, Double-blind, Parallel-group, controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers with PN400 (esomeprazole/naproxen) versus diclofenac/misoprostol in Subjects Who are at High Risk for Developing NSAID-associated Ulcers. P400-303
• A 12-Month, Phase 3, Open-Label, Multi-center Study to Evaluate the Long-term Safety of PN400 in Subjects Who are at Risk for Developing NSAID-associated ulcers. P400-304
• Randomized, Double-Blind, Parallel-Group, Placebo Controlled Multi-Center Study Evaluating the Efficacy of PN400 BID and Celeoxib 200 mg QD in Patients with OA of the Knee. P400-309
• A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinal Therapy dated July 24, 2007 previously provided to Investigator under separate cover. Reg619
• A Randomized, double-blind, placebo-controlled, parallel group trial of Cyclamen Europaeum extract nasal spray 10% in the treatment of subjects with acute sinusitis. D08
• A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Study to Evaluate the Efficacy, Safety, Pharma of BG9924 When Given in Combination with Methotrexate to Subjects with Active Rheumatoid Arthritis of the Knee who have had Inadequate Response to Anth. Bio203
• A Phase II randomized, observer blind, Multicenter study of Sponsor’s combined measles-mumps-rubella-varicella vaccine (MMRV) versus ProQuad, according to a one dose schedule, both administered subcutaneously at 12-14 months of age, concomitantly with hepatitis A vaccine (HAV) and pneumococcal conjugate vaccine (PCV) but at separate sites. MMRV054
• Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Externa. AL13
• A Phase IIb/III, Multicenter, Randomized, double-blind, placebo-controlled, dose-range finding clinical trial of MD-0941 in the treatment of Acute Migraine in patients with Type 2 Diabetes Melitus with inadequate glycemic control on Insulin. M7
• A multicenter, randomized, double-blind, placebo- and active-controlled, crossover study to evaluate the safety and efficacy of MK-0974 in the treatment of Acute Migraine in patients with stable vascular disease. M34
• A Phase IIb, multicenter, randomized, placebo-controlled clinical trial to study the safety and efficacy of MK-0974 for Migraine Prophylaxis in patients with episodic migraine. M49
• A randomized, evaluator-blinded, phase 3 study to compare the safety and efficacy of PTK 0796 with Linezolid in the treatment of adults with complicated skin and skin structure infection. Ptk
• A Phase III, double-blind, randomized, placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS). Rch
• A Survey to assess the impact of Neuropathic-pain Treatment. Snt
• A double-blind, placebo-controlled, randomized, multi-center, dose-finding study of SLV320, a selective A1 Adenosine Receptor Antagonist, to evaluate the effect on Renal function and safety in subjects hospitalized with Acute Decompensated Heart Failure and Renal Dysfunction. Slvy
• A multi-center, randomized, double-blind, active-controlled study of the safety and efficacy of Riloacept administered subcutaneously for the treatment of an acute gout flare. Reg 814
• A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy. Reg810
• A Worldwide, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study to Evaluate Efficacy a Tolerability of MK-0736, Added to Ongoing Therapy with Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker in Patients with Type 2 Diabetes Mellitus & Hypertension. M736
• A Phase IIb/III, Multicenter, Randomized, Double- Blind, Placbo-Controlled, Dose-Range Finding Clinical Trial of MK- 0941 in Patients with Type 2 Diabetes Mellitus with Inadequate Gycemic Control on Insulin. M007
• A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addiiton to Standard of Care in Subjects with a History of Atheroscierotic Disease: Thrombimn Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events. TRA
• Programming Implantable Cardioverter Defibrillators in Patients with Primary Prevention Indication to Prolong Time to First Shock. Provide
• Reducing Episodes by Septal Pacing Efficacy Confirmation Trial. Respect
• Registry of AT/AF Episodes in the CRM Device Population. Rate
• A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban with Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects with Non-Valvular Atrial Fibrillation. Rocket
• A Phase III, Double-Blind, Randomized Placebo-Controlled Study to Evaluate the Effects of RO4607381 on Cardiovascular Risk in Stable CHD Patients, with a Documented Recent Acute Coronary Syndrome. R20971
• A Long Term, Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation who Completed the RELY Trial and a Cluster Randomized Trial to Access the Effect of a Knowledge Translation Intervention on Patient Outcomes. Relyable
• Evaluation of Pharmacokinetics and Safety of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System in De Nova Native Coronary Artery Lesions. Endeavor
• A Phase III, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation. Aristotle
• A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin vs Simvastatin Monotherapy in High-Risk Subjects Presenting with Acute Coronary Syndrome. Improve It
• Registry to Evaluate Anticoagulation in Atrial Fibrillation. Real AF
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral BG9928 in Patients with Heart Failure and Renal Insufficiency. Poseidon
• A 6-Month, Phase III, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers. P301
• A 12-Month, Phase III, Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of PA3254 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers. P303
• A Safety and Efficacy Trial Evaluating the Use of APIXIBAN in the Treatment of Symptomatic Vein Thrombosis and Pulmonary Embolism. P056
• A Safety and Efficacy Trial Evaluation of the use of Apixiban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism. P057
• A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety and Efficacy of Febuxostat and Allopurinol in Subjects with Cardiovascular Comrbidities. Hyperuricemia and Gout. T-Gout
• A Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Tranilast in Combination with Allopurinol, Compared with Tranilast Alone and Allopurinol alone, in Patients with Severe Gout. N-Gout
• A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban versus (LM) Heparin/Warfarin in Subjects with Symptomic Deep-Vein Thrombosis and/or Pulmonary Embolism. DSP
• A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy study of Sitaxsentan Sodium in Subjects with Pulmonary Arterial Hypertension. P1
• A Phase III, Multi-Center, Open-Label, Study to Evaluate the Long-term Safety of Monotherapy Sitaxsentan Sodium and Combination Therapy with Sitaxsentan Sodium and Sildenafil Citrate in Subjects with Pulmonary Arterial Hypertension. P2
• A Phase III, Multi-Center, Randomized, Double-Blind, Efficacy and Safety Study of Monotherapy Sitaxsentn Sodium versus Combination Therapy with Sitaxsentan Sodium and Sildenafil Citrate in Subjects with Pulmonary Arterial Hypertension Who Have Completed B132001. P3
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogiptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome. T402
• A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine. M065
• Long-Term Evaluation of the Linox Family ICD Leads Registry. BioG
• A Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia. Harmony
• A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients with Recent Onset Symptomatic Atrial Fibrillation. ACT5
• Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry. BioC
• A Randomized, Open-Label Study Comparing the Efficacy, Safety and Tolerabiity of Oral Administration of Amantadine and Ribavirin with Oseltamivir Versus Oseltamivir Versus Oseltamivir to Influenza-A Virus Infected Immunocompromised Subjects. A206
• A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Dronedarone 400mg BID for 12 weeks on Atrial Fibrillation Burden in Subjects with Permanent Pacemakers. SA316
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter study to Evaluate Cardiovascular Outcomes during Treatment with Lisxisenatide in Type 2 Diabetic Patients after an Acute Coronary Syndrome. SA319
• International, Multi-Center, Study of a Twenty-Eight Week, Open Label, Titrated Oral Lixivaptan Administration in Patients with Chronic Hyponatremia Extension to Studies CK-LX 3401, 3405, and 3430. Harmony Ext
• Appraise-2 Apixaban for Prevention of Acute Ischemic Safety Events – 2. A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban in Subjects with a Recent Acute Coronary Syndrome. BMS068
• Prospective Multicenter Imaging Study for Evaluation of Chest Pain. Promise
• A randomized, double-blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID in patients with permanent atrial fibrillation and additional risk factors Permanent Atrial Fibrillation outcome study using Dronedarone on top of standard therapy. SA405, Pallas
• A Phase II, Open-Label, Dose Exposure Confirmation Study to Evaluate the Pharmacokinetic and Safety and Tolerability of Betrixaban (MK-4448) in Adult Patients with Non-Valvular Atrial Fibrillation or Atrial Flutter. M006
• A Randomized, Double-Blind, Parallel-Group to Evaluate the effects of First Line Treatment with a Free Combination of Nebivolol and Lisinopril Compared with Placebo and the Monotherapy Components on Blood Pressure in Patients with Stage 2 Diastolic Hypertension. Neb:25.
• A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban versus (LMW) Heparin/Warfarin in Subjects with Symptomatic Deep-Vein Thrombosis and/or Pulmonary Embolism. Hokusai
• Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D). Alecardio
• A Phase III, Randomized, Double-Blind, Cross-over Trial of Apadenoson for the Detection of Myocardial perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusiom Imaging (MPI). Aspect
• A Phase IIIb, 24-Week, Randomized, Placebo-Controlled, Double-Blinded, Efficacy and Safety Study of Linagliptin in Black/African American patients with Type II Diabetes with MMT Sub-Study. BR1218
• A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Cross-over Trial to Evaluate the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging. Gil103
• The IMPACT of Biotronik Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with ICD and CRT-D Devices. Impact
• A Phase 3, Multicenter, Randomizes, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an inadequate Response to one or more TNF-A Inhibitors. LBCDV
• A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY212399 in Patients with Rheumatoid Arthritis (RA). LBCDP
• A randomized, double-blind, active-controlled study of canakinumab (ACZ885) pre-filled syringes or reconstituted lyophilizate versus triamcinolone acetonide for treating acute gouty arthritis flares in frequently flaring patients. No2361.
• Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. Orbit
• An Observational Prospective Registry to Identify Demographic and Clinical Characteristics of Patients Hospitalized with Euvolemic and Hypervolemic Hyponatremia and Assess the Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization. Otsuka
• A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Dronedarone 400mg BID on Cardiac Geometry and Function in Patients with Atrial Fibrillation and Left Atrial Enlargememt. Odysseus
• A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Subjects with Opioid-Induced Bowel Dysfunction. Suc
• Observational Study Description H7T-US-B007 The TRANSLATE-ACS Study: Treatment with ADP receptor iNhibitorsS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary S Translate
• A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP. No2301
• A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilzumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). GEN204