Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
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
1 other identifier
interventional
66
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2000
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
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedApril 9, 2020
April 1, 2020
1.7 years
October 5, 2015
April 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-C - percent change from baseline at Week 8
56 days
Secondary Outcomes (3)
Plasma lipid levels - percent change from baseline at Week 8
56 days
Adverse Events
56 days
Clinical Laboratory
56 days
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo treatment on stable background statin therapy
Gemcabene 300 mg QD
EXPERIMENTALGemcabene (also known as CI-1027) treatment on stable background statin therapy
Gemcabene 900 mg QD
EXPERIMENTALGemcabene (also known as CI-1027) treatment on stable background statin therapy
Interventions
Eligibility Criteria
You may qualify if:
- Males and Females
- to 65 years of age
- Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27678439DERIVED
MeSH Terms
Conditions
Interventions
Condition 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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 8, 2015
Study Start
August 1, 2000
Primary Completion
April 1, 2002
Study Completion
April 1, 2002
Last Updated
April 9, 2020
Record last verified: 2020-04