- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02591836
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Active Comparator: Atorvastatin 10 mg
|
Atorvastatin
|
Active Comparator: Atorvastatin 80 mg
|
Atorvastatin
|
Experimental: Gemcabene 300 mg
Gemcabene 300 mg QD
|
Gemcabene
|
Experimental: Gemcabene 600 mg
Gemcabene 600 mg QD
|
Gemcabene
|
Experimental: Gemcabene 900 mg
Gemcabene 900 mg QD
|
Gemcabene
|
Active Comparator: Atorvastatin 40 mg
|
Atorvastatin
|
Experimental: Gemcabene 300 mg & Atorvastatin 10 mg
|
Atorvastatin
Gemcabene
|
Experimental: Gemcabene 300 mg & Atorvastatin 40 mg
|
Atorvastatin
Gemcabene
|
Experimental: Gemcabene 300 mg & Atorvastatin 80 mg
|
Atorvastatin
Gemcabene
|
Experimental: Gemcabene 600 mg & Atorvastatin 10 mg
|
Atorvastatin
Gemcabene
|
Experimental: Gemcabene 600 mg & Atorvastatin 40 mg
|
Atorvastatin
Gemcabene
|
Experimental: Gemcabene 600 mg & Atorvastatin 80 mg
|
Atorvastatin
Gemcabene
|
Experimental: Gemcabene 900 mg & Atorvastatin 10 mg
|
Atorvastatin
Gemcabene
|
Experimental: Gemcabene 900 mg & Atorvastatin 40 mg
|
Atorvastatin
Gemcabene
|
Experimental: Gemcabene 900 mg & Atorvastatin 80 mg
|
Atorvastatin
Gemcabene
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
LDL-C percent change from baseline
Time Frame: 56 days
|
56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HDL-C percent change from baseline
Time Frame: 56 days
|
56 days
|
|
TG percent change from baseline
Time Frame: 56 days
|
56 days
|
|
Apolipoprotein-B percent change from baseline
Time Frame: 56 days
|
56 days
|
|
Adverse Events
Time Frame: 56 days
|
56 days
|
|
Clinical Laboratory
Time Frame: 56 days
|
Clinical Laboratory Abnormalities
|
56 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- A4141001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolemia
-
National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
-
Direct PlantesUnknownHYPERCHOLESTEROLEMIAFrance
-
Chong Kun Dang PharmaceuticalRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Addpharma Inc.CompletedPrimary HypercholesterolemiaKorea, Republic of
-
JW PharmaceuticalCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Provident Clinical ResearchGlaxoSmithKlineUnknownPrimary HypercholesterolemiaUnited States
-
Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
-
Boryung Pharmaceutical Co., LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Ahn-Gook Pharmaceuticals Co.,LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States