Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SCH 900271 · 1 trial · 2 indications
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...
SCH 900271 is an investigational small molecule developed for the treatment of primary hypercholesterolemia, a condition marked by elevated LDL cholesterol. It was also studied in mixed hyperlipidemia. It is not approved and remains in clinical development.
SCH 900271 is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The compound carries the Schering-Plough style SCH designation, reflecting Merck's development pipeline.
SCH 900271 is in Phase 2 development. A single Phase 2 dose-ranging trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.
SCH 900271 has been evaluated in one Phase 2 trial, NCT00941603, titled a Phase 2 Dose-Ranging Efficacy and Safety Trial in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia. The trial is completed and enrolled 619 participants.
The Phase 2 trial NCT00941603 was a randomized, double-blind, placebo-controlled dose-ranging study of SCH 900271 in adults with primary hypercholesterolemia or mixed hyperlipidemia. It enrolled 619 participants aged 18 years and older and has been completed.