NCT00941603

Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)

A Phase 2 Randomized, Double-Blind, Dose-Response Efficacy and Safety Study of SCH 900271 Compared to Placebo in Subjects With Primary Hypercholesterolemia (Familial and Nonfamilial) or Mixed Hyperlipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The safety of SCH 900271 in this participant population will also be evaluated.

Conditions

• Primary Hypercholesterolemia
• Mixed Hyperlipidemia

Interventions

Type	Name	Description
DRUG	SCH 900271 15mg	oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks
DRUG	SCH 900271	oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
DRUG	SCH 900271	oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
DRUG	SCH 900271	oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
DRUG	SCH 900271	oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
DRUG	Placebo	oral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.

Timeline

• Start date: 2009-06-29
• Primary completion: 2010-02-22
• Completion: 2010-02-22
• First posted: 2009-07-17
• Last updated: 2018-09-25
• Results posted: 2016-04-12