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 2, multi-center, 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
Merck: A clinical trial comparing the efficacy and safety of a sitagliptin-based treatment paradigm to a liraglutide-based treatment paradigm in patients with type-2 diabetes mellitus who have inadequate glycemic control (4/11-12/11). PI: Scott Merryman, MD; Sub-I's: Patrick Fahey, MD, Fred Miser, MD, Paula Smailes RN, MSN, and Joan Allen, RN, MBA
Forest: A Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of Dutogliptin in patients with type 2 diabetes mellitus on background treatment with Pioglitazone 9/09-7/10. PI: Fred Miser, MD Sub-I's: Patrick Fahey, MD, Scott Merryman, MD, Paula Smailes RN, MSN, and Joan Allen, RN, MBA
Forest: A Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of Dutogliptin in patients with type 2 diabetes mellitus on background treatment with Glimepiride with or without Metformin 9/09-7/10. PI: Fred Miser, MD Sub-I's: Patrick Fahey, MD, Scott Merryman, MD, Paula Smailes RN, MSN, and Joan Allen, RN, MBA
Merck: A Phase 3, randomized, active-comparator (Metformin) controlled, clinical trial to study the efficacy and safety of MK-0431A in patients with type 2 diabetes mellitus 11/07-5/09. PI: Fred Miser, MD Sub-I's: Patrick Fahey, MD, Scott Merryman, MD, Paula Smailes RN, MSN, and Joan Allen, RN, MBA
Merck: A multi-center, randomized, double-blind study of the co-administration of Sitagliptin and Pioglitazone in patients with type 2 diabetes mellitus who have inadequate glycemic control 11/08-1/11. PI: Fred Miser, MD Sub-I's: Patrick Fahey, MD and Scott Merryman, MD
Bristol Myers Squibb: A multi-center, 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 multi-center, 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, multi-center 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 3/06-10/09. PI: Fred Miser, MD Sub-I's: Patrick Fahey, MD and Scott Merryman, MD
Merck: A multi-center, 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's: Patrick Fahey, MD and Scott Merryman, MD
Merck: A multi-center 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 multi-center, 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 2 diabetes 7/04-6/05. PI: Fred Miser, MD
Merck: A multi-center, 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 12-week, multi-center, randomized, double blind, active control parallel group study to evaluate efficacy and safety of the combination of Valturna and Amlodipine or Valturna and Chlorthalidone versus Valturna alone in patients with stage 2 hypertension
(5/11-1/12). PI: Patrick Fahey, MD Sub-I's: Fred Miser, MD, Paula Smailes RN, MSN, and Joan Allen, RN, MBA
Novartis: A 6-week, multi-center, 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: A 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's: Fred Miser, MD and Randy Wexler, MD
Sanofi Pasteur: Efficacy study of Fluzone high dose Trivalent vaccine compared with Fluzone vaccine in elderly adults (9/11-5/12). PI: Fred Miser, MD Sub-I's: Patrick Fahey, MD, Randy Wexler, MD, Paula Smailes RN, MSN, Jeanette Davis, RN, Joan Allen, RN, MBA , and Angela King.
Sanofi Pasteur: A multi-year efficacy study of Fluzone high-dose Trivalent vaccine compared with Fluzone® vaccine In Adults ≥65 years of age 9/09-5/10. PI: Fred Miser, MD Sub-I's: Patrick Fahey, MD, Scott Merryman, MD, Ramana Kankanala, MD, Paula Smailes RN, MSN, and Joan Allen, RN, MBA
Merck: A double-blind, randomized, controlled, multi-center 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 3 clinical trial to evaluate the efficacy, immunogenicity, safety and tolerability of ZOSTAVAX™ in Subjects 50 to 59 years of age 3/08-12/09. PI: Fred Miser, MD Sub-I: Patrick Fahey, MD
GlaxoSmithKline: A 7-month, multi-center, 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