NCT01350141CompletedPhase 2
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 Maximum Dose Of Atorvastatin Or Rosuvastatin.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 46
- Locations
- 35
- Primary Endpoint
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
Study Overview
Brief Summary
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Body Mass Index (BMI) of 18.5 to 40 kg/m2
- •On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day
- •Lipids meet the following criteria twice during screening period:
- •Fasting LDL C = or > 80 mg/dL;
- •Fasting TG < 400 mg/dL.
Exclusion Criteria
- •History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past year.
- •Poorly controlled type 1 or type 2 diabetes mellitus.
- •Poorly controlled hypertension.
- •Fasting triglycerides > 400 mg/dL
- •12 lead ECG demonstrating QTcFF >455 msec at screening.
Arms & Interventions
Treatment C
Experimental
Intervention: PF-04950615 (RN316) (Drug)
Treatment A
Placebo Comparator
Intervention: Placebo (Other)
Treatment B
Experimental
Intervention: PF-04950615 (RN316) (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
Time Frame: Baseline, Day 85
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Secondary Outcomes
- Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)(Day 29, 57, 85)
- Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)(Day 29, 57, 85)
- Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters(Screening up to Day 141)
- Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)(Day 1 up to Day 141)
- Change From Baseline in Lipid Parameters at Day 29, 57 and 85(Baseline, Day 29, 57, 85)
- Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85(Baseline, Day 29, 57, 85)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Day 1 up to Day 141)
- Number of Treatment-Emergent Adverse Events (TEAEs) by Severity(Day 1 up to Day 141)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Screening up to Day 141)
Investigators
Study Sites (35)
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