Randomized Clinical Trial of RN316 (PF-04950615) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events (SPIRE-LDL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01968967
First received: October 21, 2013
Last updated: July 24, 2014
Last verified: July 2014

October 21, 2013
July 24, 2014
October 2013
December 2015   (final data collection date for primary outcome measure)
Percent Change from Baseline in LDL-C at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Low Density Lipoprotein Cholesterol (LDL-C)
Same as current
Complete list of historical versions of study NCT01968967 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Lipid Parameters at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change in Total Cholesterol (TC), Apolipoprotein B (Apo B), non-HDL-C, LDL-C by TG level (< or >+ 200 mg/dL), Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.
  • Change from Baseline in Lipid Parameters at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.
  • Change from Baseline in Lipid Parameters at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.
  • Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL
  • Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL
  • Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL
  • Plasma PF-04950615 concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration
  • Plasma PF-04950615 concentration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration
  • Plasma PF-04950615 concentration [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration
Same as current
Not Provided
Not Provided
 
Randomized Clinical Trial of RN316 (PF-04950615) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study To Assess The Efficacy, Long-Term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of RN316 (PF-04950615) to lower LDL-C.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Drug: PF-04950615
    150 mg every 2 weeks, subcutaneous injection, 18 months
    Other Name: RN316
  • Other: Placebo
    subcutaneous injection every 2 weeks for 18 months
  • Experimental: PF-04950615
    Intervention: Drug: PF-04950615
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treated with a statin.
  • Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
  • High or very high risk of incurring a cardiovascular event.

Exclusion Criteria:

  • Pregnant or breastfeeding females.
  • Cardiovascular or cerebrovascular event of procedures during the past 30 days.
  • Congestive heart failure NYHA class IV.
  • Poorly controlled hypertension.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Canada,   Colombia,   France,   Hungary,   Lithuania,   Romania,   Spain,   Taiwan,   United Kingdom
 
NCT01968967
B1481020
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP