NCT02591836

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: NeuroBo Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Gemcabene	Gemcabene
DRUG	Atorvastatin	Atorvastatin
DRUG	Placebo

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2015-10-30
• Last updated: 2020-04-09