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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

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ClinicalTrials.gov Identifier: NCT02571257
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : October 14, 2015
Sponsor:
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

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

U.S. FDA Resources

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 ]


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

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02571257     History of Changes
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.:
LDL-C
Lipid Regulator

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents