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Trial record 1 of 1 for:    NCT02591836
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Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin

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.
 
ClinicalTrials.gov Identifier: NCT02591836
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date October 30, 2015
Study Start Date  ICMJE January 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
LDL‐C percent change from baseline [ Time Frame: 56 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
  • HDL-C percent change from baseline [ Time Frame: 56 days ]
  • TG percent change from baseline [ Time Frame: 56 days ]
  • Apolipoprotein-B percent change from baseline [ Time Frame: 56 days ]
  • Adverse Events [ Time Frame: 56 days ]
  • Clinical Laboratory [ Time Frame: 56 days ]
    Clinical Laboratory Abnormalities
Original Secondary Outcome Measures  ICMJE Same as current
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 as Monotherapy or in Combination With Atorvastatin
Official Title  ICMJE An 8‐Week, Double‐Blind, Randomized, Placebo‐Controlled, Dose‐Ranging Study of the Efficacy and Safety of Gemcabene Administered as Monotherapy or in Combination With Atorvastatin in the Treatment of Hypercholesterolemic Patients
Brief Summary

The primary purpose of this placebo-controlled study is to evaluate the low‐density lipoprotein cholesterol (LDL‐C) efficacy and dose‐response of gemcabene 300, 600 and 900 mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day to hypercholesterolemic patients.

Secondary purposes include evaluating the effects of high‐sensitivity C-reactive protein (hsCRP), high‐density lipoprotein cholesterol (HDL‐C), triglycerides (TG) and apolipoprotein B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin combination.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: Gemcabene
    Gemcabene
  • Drug: Atorvastatin
    Atorvastatin
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Gemcabene 300 mg
    Gemcabene 300 mg QD
    Intervention: Drug: Gemcabene
  • Experimental: Gemcabene 600 mg
    Gemcabene 600 mg QD
    Intervention: Drug: Gemcabene
  • Experimental: Gemcabene 900 mg
    Gemcabene 900 mg QD
    Intervention: Drug: Gemcabene
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Atorvastatin 10 mg
    Intervention: Drug: Atorvastatin
  • Active Comparator: Atorvastatin 40 mg
    Intervention: Drug: Atorvastatin
  • Active Comparator: Atorvastatin 80 mg
    Intervention: Drug: Atorvastatin
  • Experimental: Gemcabene 300 mg & Atorvastatin 10 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
  • Experimental: Gemcabene 300 mg & Atorvastatin 40 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
  • Experimental: Gemcabene 300 mg & Atorvastatin 80 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
  • Experimental: Gemcabene 600 mg & Atorvastatin 10 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
  • Experimental: Gemcabene 600 mg & Atorvastatin 40 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
  • Experimental: Gemcabene 600 mg & Atorvastatin 80 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
  • Experimental: Gemcabene 900 mg & Atorvastatin 10 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
  • Experimental: Gemcabene 900 mg & Atorvastatin 40 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
  • Experimental: Gemcabene 900 mg & Atorvastatin 80 mg
    Interventions:
    • Drug: Gemcabene
    • Drug: Atorvastatin
Publications * Not Provided

*   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 28, 2015)
277
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and Females
  • 18‐70 years old
  • Received a statin as monotherapy while having a LDL‐C >100 mg d/L at initial clinical washout visit OR
  • Received no lipid‐altering drugs since the initial clinic washout visit and had a mean LDL‐C as follows at 2 qualifying visits:

    • ≥ 130 mg/dL if National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Coronary Heard Disease (CHD) risk ≥ 10%; OR
    • ≥ 160 mg/dL if NCEP ATP III CHD risk < 10%
  • Had variability of 2 qualifying LDL‐C <20% (i.e. lowest value/highest value >0.8). An additional qualifying visit may have been completed by patients who were washing off lipid medication in order to reassess LDL‐C variability; and
  • Had a mean LDL‐C < 250 mg/dL at 2 qualifying visits

Exclusion Criteria:

  • Women of childbearing potential, pregnant or lactating;
  • Body Mass Index (BMI) >38kg/m²;
  • TG >400 mg/dL at Visit B2 or B3
  • Unexplained creatinine phosphokinase (CPK) > 3 x Upper Limit of Normal (ULN) or those with a history of unexplained myopathy (including rhabdomyolysis);
  • Documented cardiac history of: Myocardial infarction*, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, symptomatic carotid artery disease or peripheral artery disease, ventricular arrhythmias, recurrent supraventricular tachycardia, abnormal QTC interval (QT corrected > 0.44 sec), heart failure or any other major cardiovascular event resulting in hospitalization
  • Uncontrolled hypertension*
  • Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c >8%) or any diabetic patient who takes insulin and/or thiazolidinediones
  • Renal dysfunction including chronic renal failure or insufficiency, or creatinine >2.0 mg/dL;
  • Hepatic dysfunction
  • Uncontrolled hypothyroidism
  • Abnormal urinalysis
  • Currently taking any of the following medications:

    • Potent CYP3A4 inhibitors including indinavir, nelfinavir, ritonavir, saquinavir, amiodarone, cimetidine, clarithromycin, erythromycin, erythromycin, fluoxetine, itraconazole, ketoconazole, nefazodone and troleandomycin as well as grapefruit juice;
    • Thiazolidinediones (Avandia, Actos);
    • Immunosuppressive agents;
    • St. John's wort
  • Taking any of the following lipid‐altering medications within 5 weeks prior to randomization:

    • Lipid‐regulating drugs: Niacin (crystalline >500mg/day, slow release or time release), psyllium preparation such as Metamucil (>2 tablespoons/day), fibrates and derivatives, bile cholesterol absorption inhibitors including ezetimibe;
    • Any supplement containing plan sterols/stanols (i.e. Benecol, beta‐sitosterol, Cholestatin, Phytoquest, Take Control) or cholestin (i.e. Chinese red yeast, fermented on rice; Hong Qu, Hong Chu, Herbvalin, Ruby Monascus, Monascus purpureus rice);
    • Neomycin (oral);
    • Adrenocortical steroids*
    • Sibutramine (Meridia);
    • Insulin;
    • Orlistat (Xenical);
    • Isotretinoin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 NCT02591836
Other Study ID Numbers  ICMJE A4141001
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