Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Statin · 1 trial · 2 indications
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
| Arm | Type | Description |
|---|---|---|
| Treatment A | PLACEBO_COMPARATOR | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | EXPERIMENTAL | - |
| Treatment E | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Intravenous placebo monthly during treatment phase. |
| Statin | DRUG | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
| PF-04950615 (RN316) | BIOLOGICAL | Intravenous 10mg/mL based on weight monthly during treatment phase. |
| Satin | DRUG | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
Inclusion Criteria: * On a stable daily dose of atorvastatin, rosuvastatin or simvastatin. * Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL Exclusion Criteria: * History of a cardiovascular or cerebrovas...
Statin is used for hypercholesterolemia, a condition of high cholesterol levels. It is being developed as a small molecule therapy for cardiovascular indications. The drug is currently in clinical development and has completed a Phase 2 trial.
Statin is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Statin is in Phase 2 of clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities.
Statin has been studied in one clinical trial with the identifier NCT01342211. This Phase 2 trial, titled 'A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins,' was completed and enrolled 93 participants with hypercholesterolemia or dyslipidemia.
Statin is also known as PF-04950615 and RN316. These names refer to the same investigational drug being developed by Pfizer for hypercholesterolemia. The clinical trial NCT01342211 used the name PF-04950615 in its title.