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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Hyperlip

Brief 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.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Change From Baseline in Direct LDL-C at Week 8 [ Time Frame: Baseline and Week 8 ]

The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.


Original Primary Outcome: To determine 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. [ Time Frame: 8 weeks after baseline measurement ]

Current Secondary Outcome: Change From Baseline in Direct Non-HDL-C at Week 8 [ Time Frame: Baseline and Week 8 ]

The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.


Original Secondary Outcome: To determine the effect of SCH 900271 compared to placebo on the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to 8 weeks of treatment. [ Time Frame: 8 weeks after baseline measurement ]

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: July 16, 2009
Date Started: June 2009
Date Completion:
Last Updated: April 27, 2016
Last Verified: April 2016