drugset / Trial / NCT02591836
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin
RandomizedFactorialQuadruple-blindTreatment
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.
Timeline
- Start
- 2003-01
- Primary completion
- 2003-06
- Completion
- 2003-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 10 mg | — |
| Subject | Atorvastatin | Small molecule | 40 mg | — |
| Subject | Atorvastatin | Small molecule | 80 mg | — |
| Subject | Gemcabene | Small molecule | 300 mg | — |
| Subject | Gemcabene | Small molecule | 600 mg | — |
| Subject | Gemcabene | Small molecule | 900 mg | — |