drugset / Trial / NCT00941603

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

NCT00941603 ↗

Phase 2 Completed 619 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-06-29
Primary completion
2010-02-22
Completion
2010-02-22

Outcome

Met primary endpoint

registry SCH 900271 5 mg vs Placebo; p <0.01; Difference in percent -5.7 (95% CI -9.4 to -2.0); ANOVA NCT00941603 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject SCH 900271 Small molecule 1 mg Oral
Subject SCH 900271 Small molecule 2.5 mg Oral
Subject SCH 900271 Small molecule 5 mg Oral
Subject SCH 900271 Small molecule 10 mg Oral
Subject SCH 900271 Small molecule 15 mg Oral