Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00941603 | Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675) | PHASE2 | COMPLETED | 619 | — | — | Jun 29, 2009 | Feb 22, 2010 | Sep 25, 2018 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| SCH 900271 15 mg | EXPERIMENTAL | Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks |
| SCH 900271 10 mg | EXPERIMENTAL | Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks |
| SCH 900271 5 mg | EXPERIMENTAL | Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks |
| SCH 900271 2.5 mg | EXPERIMENTAL | 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 |
| SCH 900271 1 mg | EXPERIMENTAL | Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks |
| Name | Type | Description |
|---|---|---|
| SCH 900271 15mg | DRUG | oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks |
| SCH 900271 | DRUG | oral tablets; SCH 900271 10 mg taken once daily for 8 weeks |
| Placebo | DRUG | 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. |
Inclusion Criteria: * Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides \[TG\]) * must be free of any clinically significant disease, other than primary hyperc...