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Diabetic Complications
2010 - PI - Leslie Klaff, MD, Ph D (Phase 2b)
A Phase IIb Repeat Dosing Clinical Trial of An Investigational Medication in Subjects with Moderately Severe Diabetic Neuropathy
2009 PI – Leslie Klaff, MD, Ph.D (Phase 2b)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety,and Tolerability of An Investigational Medication in Subjects with Diabetic Peripheral Neuropathy, Followed by a Double-Blind Safety Extension and an Open-Label Safety Extension
2007 PI - Leslie Klaff, MD, Ph D (Phase 2)
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of the Effect of An Investigational Medication At Two Doses for 24 Weeks Treatment on the Rate of Regeneration of Epidermal Nerve Fibers in Patients with Mild Diabetic Peripheral Neuropathy
2007 PI - Leslie Klaff, MD, Ph D (Phase 2)
A Phase II Repeat Dosing Clinical Trial of An Investigational Medication in Subjects with Moderate to Severe Diabetic Neuropathy and Unmeasurable Nerve Conduction Velocity.
2007 PI - Leslie Klaff, MD, Ph D (Phase 3)
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine Whether, In Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, An FDA Approve Medication, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality
2007 PI – Allen Sussman, MD (Phase II)
A Phase II Study of an Investigational Topical Medication for the Treatment of Symptomatic Diabetic Peripheral Neuropathy
2006 PI – Ronald Brazg, MD (Phase II)
A Phase II, Randomized, Double-Blinded, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20 mg, 40 mg and 80 mg of An Investigational Medication in Patients with Mild to Moderate Diabetic Polyneuropathy
2005 PI – Ronald Brazg, MD (Phase II)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 2 Study Designed to Assess the Efficacy and Safety of An Investigational Medication in Subjects with Painful Diabetic Neuropathy
2004 PI – Leslie Klaff, MD, PhD. (Phase III)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study of the Efficacy and Safety of an investigational medication in Patients With Diabetic Sensorimotor Polyneuropathy
2004 PI Ronald Brazg, MD (Phase II)
A Randomized, Double-Blind Placebo-Controlled, Flexible Dose Study of the efficacy and Safety of an investigational medication in Comparison to Gabapentin In Patients With Painful Diabetic Neuropathy
2003 PI – Leslie Klaff, MD (Phase III)
Double-Blind Comparison of the efficacy and safety of an investigational medication versus Hydrochlorothiazide as add-on therapy to Ramipril 10 MG QD in Diabetic Hypertensive patients with Macroalbuminuria
2003 PI – Ronald Brazg, MD (Phase IV)
A Multi-center, Double-blind, Randomized, Parallel Group Study to Evaluate the Effects of an investigational medication on Microalbuminuria in Hypertensive Subjects with Type 2 Diabetes Mellitus (DM)
2002 PI – Leslie Klaff, MD (Phase II)
An open – label dose escalation study of an investigational medication in patients with painful diabetic neuropathy.
2002 PI- Leslie Klaff, MD (Phase II)
A randomized, double-blind, placebo-controlled, multi-center, 24-week study to evaluate the safety and tolerability of an investigational medication in patients with diabetic nephropathy associated with type 1 or type 2 diabetes.
2002 PI - Leslie Klaff, MD, Ph.D.
A randomized, double-blind, placebo-controlled, multi-center, 24-week study to evaluate the safety and tolerability of an investigational medication in patients with diabetic nephropathy associated with type 1 or type 2 diabetes.
2001 PI - Leslie Klaff, MD, Ph.D.
Evaluation of the Safety and Efficacy of An Investigational Medication in the Treatment of Chronic Pain in Patients with Diabetic Neuropathy
2001 PI - Allen Sussman, MD.
A Multicenter, Efficacy and Safety Assessment of An Investigative Medication In Patients With Painful Diabetic Neuropathy
2001 PI - Leslie Klaff, MD, Ph.D
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of an Investigational Medication in Patients with Type 1 Diabetes and Diabetes-Associated Nephropathy
2001 PI - Leslie Klaff, MD, Ph.D
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of an Investigational Medication in Patients with Type 2 Diabetes and Diabetes-Associated Nephropathy
2000 PI - Leslie Klaff, MD, Ph.D
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of An Investigational Medication in Type 1 Diabetic Patients With Diabetes-Associated Nephropathy
2000 PI - Ronald Brazg, MD
A Phase II Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of An Investigational Medication in Subjects with Diabetic Neuropathy
1999 PI - Leslie Klaff, MD, Ph.D.
A Multicenter, Blinded, Randomized, Placebo-Controlled Study of A Topical Gel in Patients With Painful Diabetic Neuropathy
1999 PI - Leslie Klaff, MD, Ph.D.
A Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of and Investigational Medication Versus Placebo in the Relief of Pain in Diabetic Peripheral Polyneuropathy
1998 PI - Ronald Brazg, MD
A Phase II Randomized, Placebo-Controlled Dose-Ranging Trial of an Investigational Medication in Diabetic Patients with Painful Peripheral Neuropathy.
1996 PI - Leslie Klaff, MD, Ph.D.
A Multicenter, Double-blind, Placebo-Controlled, Parallel-Group Study of the Effects of an Oral Investigational Medication in Subjects With Peripheral Symmetrical Diabetic Polyneuropathy.
1993 PI - Ronald Brazg, MD
Randomized Study Comparing Two Dose Levels of an Investigational Medication and Vehicle For PC1020 Topical Gel in the Treatment of Diabetic Patients With Neuropathic Plantar Ulcers. |
Phase I & Pharmacokinetic Unit