Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemphire Therapeutics, Inc.; NeuroBo Pharmaceuticals Inc.
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

Inclusion Criteria:

• Males and Females

• 18 to 65 years of age

• Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)

Exclusion Criteria:

• If female, postmenopausal or surgically menopausal

• Triglycerides (TG) >400 mg/dL

• Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)

• Body Mass Index (BMI) >35 kg/m2

• Uncontrolled diabetes mellitus (HbA1c >10%)

• Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN)

• Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)

• Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month