Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571257
• Other study ID #: 1027-018
• Status: Completed
• Phase: Phase 2
• Start date: August 2000
• Est. completion date: April 2002

Study information

• Verified date: April 2020
• Source: NeuroBo Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and Females

• 18 to 65 years of age

• Baseline LDL-C = 130 mg/dL (3.4 mmol/L)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Gemcabene
1-300 mg tablet, QD, 56 days
• Gemcabene
3-300 mg tablets, QD, 56 days
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NeuroBo Pharmaceuticals Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C - percent change from baseline at Week 8		56 days
Secondary	Plasma lipid levels - percent change from baseline at Week 8	apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)	56 days
Secondary	Adverse Events		56 days
Secondary	Clinical Laboratory		56 days