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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02591836
First received: October 22, 2015
Last updated: October 28, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia Drug: Gemcabene Drug: Atorvastatin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • LDL‐C percent change from baseline [ Time Frame: 56 days ]

Secondary Outcome Measures:
  • 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


Enrollment: 277
Study Start Date: January 2003
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcabene 300 mg
Gemcabene 300 mg QD
Drug: Gemcabene
Gemcabene
Experimental: Gemcabene 600 mg
Gemcabene 600 mg QD
Drug: Gemcabene
Gemcabene
Experimental: Gemcabene 900 mg
Gemcabene 900 mg QD
Drug: Gemcabene
Gemcabene
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Atorvastatin 10 mg Drug: Atorvastatin
Atorvastatin
Active Comparator: Atorvastatin 40 mg Drug: Atorvastatin
Atorvastatin
Active Comparator: Atorvastatin 80 mg Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 300 mg & Atorvastatin 10 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 300 mg & Atorvastatin 40 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 300 mg & Atorvastatin 80 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 600 mg & Atorvastatin 10 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 600 mg & Atorvastatin 40 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 600 mg & Atorvastatin 80 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 900 mg & Atorvastatin 10 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 900 mg & Atorvastatin 40 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin
Experimental: Gemcabene 900 mg & Atorvastatin 80 mg Drug: Gemcabene
Gemcabene
Drug: Atorvastatin
Atorvastatin

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02591836     History of Changes
Other Study ID Numbers: A4141001
Study First Received: October 22, 2015
Last Updated: October 28, 2015

Keywords provided by Gemphire Therapeutics, Inc.:
LDL‐C
Lipid Regulator

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

ClinicalTrials.gov processed this record on July 26, 2017