Trials / Completed
CompletedNCT01342211
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
A Phase 2, Double-blind, Placebo-controlled, Randomized Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo | Intravenous placebo monthly during treatment phase. |
| DRUG | Statin | 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. |
| BIOLOGICAL | PF-04950615 (RN316) | Intravenous 10mg/mL based on weight monthly during treatment phase. |
| DRUG | Statin | 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. |
| BIOLOGICAL | PF-04950615 (RN316) | Intravenous 10mg/mL based on weight monthly during treatment phase. |
| DRUG | Statin | 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. |
| BIOLOGICAL | PF-04950615 (RN316) | Intravenous 10mg/mL based on weight monthly during treatment phase. |
| DRUG | Satin | 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. |
| BIOLOGICAL | PF-04950615 (RN316) | Intravenous 10mg/mL based on weight monthly during treatment phase. |
| DRUG | Statin | 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. |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2012-02-01
- Completion
- 2012-06-01
- First posted
- 2011-04-27
- Last updated
- 2017-10-11
- Results posted
- 2017-10-11
Locations
44 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01342211. Inclusion in this directory is not an endorsement.