A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01342211
First received: April 25, 2011
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
Biological: Placebo
Biological: PF-04950615 (RN316)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study To Assess The Efficacy, Safety, And Tolerability Of PF-04950615 (RN316)Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Observed mean percentage reduction from baseline in LDL-C [ Time Frame: Day 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving a significant decrease in LDL C from baseline. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Change and percentage change from baseline in other lipid parameters: total cholesterol, HDL C, non-HDL C, TG, ApoB, ApoA1 and Lpa. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Incidence, severity and causal relationship of treatment emergent AEs (TEAEs). [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]
  • Incidence of abnormal and clinically relevant safety laboratories including clinical chemistry, hematology and coagulation assessments. [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]
  • Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]
  • Incidence of anti-drug-antibodies. [ Time Frame: Day 141 ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Biological: Placebo
Intravenous placebo monthly during treatment phase.
Experimental: Treatment B Biological: PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Other Name: PF-04950615 (RN316)
Experimental: Treatment C Biological: PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Other Name: PF-04950615 (RN316)
Experimental: Treatment D Biological: PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Other Name: PF-04950615 (RN316)
Experimental: Treatment E Biological: PF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
Other Name: PF-04950615 (RN316)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 cerebrovascular event or procedure during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus.
  • Poorly controlled hypertension.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342211

  Show 38 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01342211     History of Changes
Other Study ID Numbers: B1481005
Study First Received: April 25, 2011
Last Updated: October 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-04950615
RN316

Additional relevant MeSH terms:
Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014