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
1 other identifier
interventional
277
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2003
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedApril 9, 2020
April 1, 2020
5 months
October 22, 2015
April 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-C percent change from baseline
56 days
Secondary Outcomes (5)
HDL-C percent change from baseline
56 days
TG percent change from baseline
56 days
Apolipoprotein-B percent change from baseline
56 days
Adverse Events
56 days
Clinical Laboratory
56 days
Study Arms (16)
Gemcabene 300 mg
EXPERIMENTALGemcabene 300 mg QD
Gemcabene 600 mg
EXPERIMENTALGemcabene 600 mg QD
Gemcabene 900 mg
EXPERIMENTALGemcabene 900 mg QD
Placebo
PLACEBO COMPARATORAtorvastatin 10 mg
ACTIVE COMPARATORAtorvastatin 40 mg
ACTIVE COMPARATORAtorvastatin 80 mg
ACTIVE COMPARATORGemcabene 300 mg & Atorvastatin 10 mg
EXPERIMENTALGemcabene 300 mg & Atorvastatin 40 mg
EXPERIMENTALGemcabene 300 mg & Atorvastatin 80 mg
EXPERIMENTALGemcabene 600 mg & Atorvastatin 10 mg
EXPERIMENTALGemcabene 600 mg & Atorvastatin 40 mg
EXPERIMENTALGemcabene 600 mg & Atorvastatin 80 mg
EXPERIMENTALGemcabene 900 mg & Atorvastatin 10 mg
EXPERIMENTALGemcabene 900 mg & Atorvastatin 40 mg
EXPERIMENTALGemcabene 900 mg & Atorvastatin 80 mg
EXPERIMENTALInterventions
Gemcabene
Atorvastatin
Eligibility Criteria
You may qualify if:
- Males and Females
- 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
You may not qualify if:
- 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;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 30, 2015
Study Start
January 1, 2003
Primary Completion
June 1, 2003
Study Completion
June 1, 2003
Last Updated
April 9, 2020
Record last verified: 2020-04