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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.

Tracking Information
First Submitted Date  ICMJE October 5, 2015
First Posted Date  ICMJE October 8, 2015
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE August 2000
Actual Primary Completion Date April 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2015)
LDL-C - percent change from baseline at Week 8 [ Time Frame: 56 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02571257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2015)
  • Plasma lipid levels - percent change from baseline at Week 8 [ Time Frame: 56 days ]
    apolipoprotein B (apoB), Total Cholesterol (TC), high sensitivity C reactive protein (hsCRP), 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: Gemcabene
    1-300 mg tablet, QD, 56 days
  • Drug: Gemcabene
    3-300 mg tablets, QD, 56 days
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo treatment on stable background statin therapy
    Intervention: Drug: Placebo
  • Experimental: Gemcabene 300 mg QD
    Gemcabene (also known as CI-1027) treatment on stable background statin therapy
    Intervention: Drug: Gemcabene
  • Experimental: Gemcabene 900 mg QD
    Gemcabene (also known as CI-1027) treatment on stable background statin therapy
    Intervention: Drug: Gemcabene
Publications * Stein E, Bays H, Koren M, Bakker-Arkema R, Bisgaier C. Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1212-22. doi: 10.1016/j.jacl.2016.08.002. Epub 2016 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2015)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2002
Actual Primary Completion Date April 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02571257
Other Study ID Numbers  ICMJE 1027-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gemphire Therapeutics, Inc.
Study Sponsor  ICMJE Gemphire Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gemphire Therapeutics, Inc.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP