CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 93 enrolled
Drug / intervention
Placebo +9 morebiological
Likely dose
Statin 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01342211
NCT01342211Phase 2Completed

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.

Pfizer·interventional·Posted Apr 27, 2011·Updated Oct 11, 2017

In Brief

A Phase 2 clinical trial evaluating Placebo, Statin, and 2 other interventions for Hypercholesterolemia and Dyslipidemia. Completed, enrolled 93 participants across 44 sites in 2 countries.

Detailed Summary

This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2011
Enrollment StartJul 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.2 years ago

Interventions

Placebobiological

Intravenous placebo monthly during treatment phase.

Statindrug

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.

Statindrug

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.

Statindrug

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.

Satindrug

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.

Statindrug

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.