drugset / Trial / NCT00941603
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |