The following Industry Sponsored Research clinical trials are ongoing or were completed in the Department of Family Medicine; however, enrollment is complete and no new participants are needed.
Centocor: A phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose finding study evaluating the safety and efficacy of infliximab administration in symptomatic subjects with moderate to severe COPD. 8/03-5/05. PI: Fred Miser, MD
Bristol Myers Squibb: A multicenter, randomized,double-blind, placebo controlled, phase 3 trial to evaluate the efficacy and safety of Saxagliptin (BMS-477118) in combination with Thiazolidinedione therapy in subjects with type 2 diabetes who have inadequate glycemic control 3/06-9/06 PI: Fred Miser, MD
Bristol Myers Squibb: A multicenter, randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate the efficacy and safety of saxagliptin (BMS-477118) in combination with metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin PI: Fred Miser, MD
Bristol Myers Squibb: A Phase 3, Randomized, Double-Blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar Compared to Pioglitazone in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control. 9/05-12/07 PI: Fred Miser, MD
ConjuChem: CJC-1131 once-a-day subcutaneous administration, in patients with type 2 diabetes mellitus treated with metformin, and comparison with patients treated with Metformin alone. 7/04-12/04. PI: Fred Miser, MD
Eli Lilly, & Co. The durability of 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 3/06-ongoing PI: Fred Miser, MD sub-I: Pat Fahey, MD, sub-I: Scott Merryman, MD
Merck: A multicenter, double-blind, randomized, parallel group study to evaluate the safety and efficacy of Sitagliptin in elderly patients with type 2 diabetes mellitus 3/07-2/09 PI: Fred Miser, MD sub-I: Pat Fahey, MD, sub-I: Scott Merryman, MD
Merck: A multicenter randomized, double-blind study to evaluate the safety and efficacy of MK-0431 monotherapy in patients with type 2 diabetes mellitus who have inadequate glycemic control 1/04-4/07 PI: Fred Miser, MD
Novartis: A multicenter, randomized, double-blind study to compare the effects of 24 weeks treatment with LAF237 (50 mg bid or 100 mg qd) to placebo in drug naive patients with type 2 diabetes 9/05-1/07 PI: Fred Miser, MD
Ross: Effect of slow digesting carbohydrate (SDC) formula on glycemic response in patients with type II diabetes 7/04-6/05 PI: Fred Miser, MD
Merck: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients with Type IIa or Type IIb Hyperlipidemia. 12/05-3/08 PI: Patrick Fahey, MD sub-I: Fred Miser, MD
Novartis A 6-Week, Multicenter, Randomized, Parallel-Group Treatment Regimen Study To Evaluate The Efficacy Of Initial High Dose Valsartan Monotherapy (160 Mg) Or Combination Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 Mg) To Conventional Low-Dose Valsartan Monotherapy (80 Mg) In Managing Patients With Hypertension. 12/05-12/07 PI: Patrick Fahey, MD sub-I: Fred Miser, MD
Novartis An 8 week Randomized, Double-Blind, Parallel Group, Multi Center, Active Controlled Study to Evaluate the Efficacy and Safety of Valsartan Administered in Combination with Aliskiren (160/150 mg, 320/300 mg) versus Valsartan alone (160 mg, 320 mg) in Patients with Stage 2 Hypertension 1/09-6/09 PI: Patrick Fahey, MD sub-I: Fred Miser, MD and sub-I: Randy Wexler, MD
Merck: A double-blind, randomized, controlled, multicenter study to evaluate the safety, tolerability and immunogenicity of a refrigerator-stable formulation of Zoster vaccine live. 8/05-12/07 PI: Fred Miser, MD,
Vaxgen: A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers 1/05-1/06 sub-I: Fred Miser, MD
Merck: A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of ZOSTAVAX™ in Subjects 50 to 59 Years of Age 3/08-ongoing PI: Fred Miser, MD sub-I: Pat Fahey, MD
GlaxoSmithKline: A 7 month, multicenter, parallel, double-blind, placebo-controlled comparison of 150-300 mg/day of extended-release bupropion hydrochloride and placebo for the prevention of seasonal depressive episodes. 5/03-12/04 PI: Fred Miser, MD,
Novartis: A 52-Week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-Term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-Label Treatment of 16-24 Weeks 5/07-ongoing sub-I: Scott Merryman, MD