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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02571257
First Posted: October 8, 2015
Last Update Posted: October 14, 2015
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.
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.
  Purpose
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 Intervention Phase
Hypercholesterolemia Drug: Gemcabene Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gemphire Therapeutics, Inc.:

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

Secondary Outcome Measures:
  • 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)

  • Adverse Events [ Time Frame: 56 days ]
  • Clinical Laboratory [ Time Frame: 56 days ]

Enrollment: 66
Study Start Date: August 2000
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02571257     History of Changes
Other Study ID Numbers: 1027-018
First Submitted: October 5, 2015
First Posted: October 8, 2015
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