Conditions: Primary Hypercholesterolemia Mixed Hyperlipidemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 619
Healthy volunteers: no

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 description:

Arms:
arm 1: Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 2: Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 3: Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 4: Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 5: Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 6: Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks

Interventions: intervention 1: SCH 900271 15mg intervention 2: SCH 900271 intervention 3: SCH 900271 intervention 4: SCH 900271 intervention 5: SCH 900271 intervention 6: Placebo
Intervention descriptions: intervention 1: oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks intervention 2: oral tablets; SCH 900271 10 mg taken once daily for 8 weeks intervention 3: oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks intervention 4: oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks intervention 5: oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks intervention 6: 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.

Protocol document: