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Trial record 1 of 1 for:    NCT02571257
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Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02571257
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Gemcabene Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin
Study Start Date : August 2000
Actual Primary Completion Date : April 2002
Actual Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo treatment on stable background statin therapy
Drug: Placebo
Experimental: Gemcabene 300 mg QD
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Drug: Gemcabene
1-300 mg tablet, QD, 56 days

Experimental: Gemcabene 900 mg QD
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Drug: Gemcabene
3-300 mg tablets, QD, 56 days

Primary Outcome Measures :
  1. LDL-C - percent change from baseline at Week 8 [ Time Frame: 56 days ]

Secondary Outcome Measures :
  1. Plasma lipid levels - percent change from baseline at Week 8 [ Time Frame: 56 days ]
    apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)

  2. Adverse Events [ Time Frame: 56 days ]
  3. Clinical Laboratory [ Time Frame: 56 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gemphire Therapeutics, Inc. Identifier: NCT02571257    
Other Study ID Numbers: 1027-018
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Gemphire Therapeutics, Inc.:
Lipid Regulator
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents