At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 354 enrolled
Drug / intervention
PBO +6 moredrug
Likely dose
200mg PF-04950615 (RN316)from 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.
A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin
In Brief
A Phase 2 clinical trial evaluating PBO, 200mg PF-04950615 (RN316), and 2 other interventions for Hypercholesterolemia. Completed, enrolled 354 participants across 74 sites.
Detailed Summary
To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is \>/=80 mg/dL on background treatment with a statin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJul 2012
Primary CompletionApr 2013
Study CompletionMay 2013
TodayJul 2026
First PostedMay 7, 2012
Enrollment StartJul 1, 2012
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.2 years ago
Interventions
PBOdrug
Placebo Q28d
200mg PF-04950615 (RN316)drug
PF-04950615 200 mg, Q28d
300mg PF-04950615 (RN316)drug
PF-04950615 300 mg, Q28d
PBOdrug
Placebo, Q14d
PF-04950615drug
PF-04950615 50mg, Q14d
PF-04950615drug
PF-04950615 100 mg, Q14d
PF-04950615drug
PF-04950615 150mg, Q14d