Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2001-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Hypercholesterolemia Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gemcabene 150 mg

Gemcabene 150 mg once daily (QD)

Group Type EXPERIMENTAL

Gemcabene 150 mg

Intervention Type DRUG

Blinded capsules and tablets, 150 mg, once daily, 84 days

Gemcabene 300 mg

Gemcabene 300 mg once daily (QD)

Group Type EXPERIMENTAL

Gemcabene 300 mg

Intervention Type DRUG

Blinded capsules and tablets, 300 mg, once daily, 84 days

Gemcabene 600 mg

Gemcabene 600 mg once daily (QD)

Group Type EXPERIMENTAL

Gemcabene 600 mg

Intervention Type DRUG

Blinded capsules and tablets, 600 mg, once daily, 84 days

Gemcabene 900 mg

Gemcabene 900 mg once daily (QD)

Group Type EXPERIMENTAL

Gemcabene 900 mg

Intervention Type DRUG

Blinded capsules and tablets, 900 mg, once daily, 84 days

Placebo

Placebo once daily (QD)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Blinded capsule and tablets, once daily, 84 days

Interventions

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Gemcabene 150 mg

Blinded capsules and tablets, 150 mg, once daily, 84 days

Intervention Type DRUG

Gemcabene 300 mg

Blinded capsules and tablets, 300 mg, once daily, 84 days

Intervention Type DRUG

Gemcabene 600 mg

Blinded capsules and tablets, 600 mg, once daily, 84 days

Intervention Type DRUG

Gemcabene 900 mg

Blinded capsules and tablets, 900 mg, once daily, 84 days

Intervention Type DRUG

Placebo

Blinded capsule and tablets, once daily, 84 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or naturally postmenopausal or surgically menopausal women
* 18 to 80 years of age
* Baseline HDL-C \<35 mg/dL (0.9 mmol/L)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No