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 being developed for primary hypercholesterolemia, a condition of elevated cholesterol levels. It is also being studied in mixed hyperlipidemia. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
SCH 900271 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical trials for primary hypercholesterolemia.
SCH 900271 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of primary hypercholesterolemia and mixed hyperlipidemia.
SCH 900271 has one completed Phase 2 clinical trial, identified as NCT00941603. This was a dose-ranging efficacy and safety study in participants with primary hypercholesterolemia or mixed hyperlipidemia. The trial enrolled 619 participants and was randomized, double-blind, and placebo-controlled.
SCH 900271 is also known as P05675, which is the protocol number used in the clinical trial NCT00941603. This trial is titled 'Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)'.