Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
1 other identifier
interventional
161
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 1999
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedApril 9, 2020
April 1, 2020
1.5 years
October 22, 2015
April 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HDL-C - percent change from baseline
84 days
Secondary Outcomes (3)
Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline
84 days
Adverse Events
84 days
Clinical Laboratory - hematology, chemistry, urinalysis
84 days
Study Arms (5)
Gemcabene 150 mg
EXPERIMENTALGemcabene 150 mg once daily (QD)
Gemcabene 300 mg
EXPERIMENTALGemcabene 300 mg once daily (QD)
Gemcabene 600 mg
EXPERIMENTALGemcabene 600 mg once daily (QD)
Gemcabene 900 mg
EXPERIMENTALGemcabene 900 mg once daily (QD)
Placebo
PLACEBO COMPARATORPlacebo once daily (QD)
Interventions
Eligibility Criteria
You may qualify if:
- Men or naturally postmenopausal or surgically menopausal women
- to 80 years of age
- Baseline HDL-C \<35 mg/dL (0.9 mmol/L)
You may not qualify if:
- Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN)
- Body Mass Index (BMI) \>35 kg/m2
- Uncontrolled Hypertension \>95 mm Hg
- 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)
- Uncontrolled hypothyroidism (TSH \>1.5 × 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 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Bays HE, McKenney JM, Dujovne CA, Schrott HG, Zema MJ, Nyberg J, MacDougall DE; Gemcabene Study Group. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol. Am J Cardiol. 2003 Sep 1;92(5):538-43. doi: 10.1016/s0002-9149(03)00721-5.
PMID: 12943873BACKGROUND
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 22, 2015
First Posted
October 23, 2015
Study Start
December 1, 1999
Primary Completion
June 1, 2001
Study Completion
June 1, 2001
Last Updated
April 9, 2020
Record last verified: 2020-04