At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SCH 900271 15mg, SCH 900271, and 1 other intervention for Primary Hypercholesterolemia and Mixed Hyperlipidemia. Completed, enrolled 619 participants.
Detailed 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.
Study Details
Timeline
Interventions
oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks
oral tablets; SCH 900271 10 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks
oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks
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.