The Evaluation Of PF-04950615 (RN316) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects (SPIRE-2)

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:
NCT01975389
First received: October 21, 2013
Last updated: July 24, 2014
Last verified: July 2014

October 21, 2013
July 24, 2014
October 2013
August 2017   (final data collection date for primary outcome measure)
Cardiovascular event [ Time Frame: The time from Randomization to the first adjudicated and confirmed occurrence of a primary endpoint major cardiovascular event, up to Month 60 ] [ Designated as safety issue: No ]
Confirmed occurrence of a major cardiovascular event, a composite endpoint which includes CV death, non fatal MI, non fatal stroke, and hospitalization for unstable angina needing urgent revascularization
Same as current
Complete list of historical versions of study NCT01975389 on ClinicalTrials.gov Archive Site
  • Hospitalization for unstable angina needing urgent revascularization [ Time Frame: The time from randomization to the first adjudicated and confirmed hospitalization for unstable angina needing urgent revascularization, assessed up to Month 60 ] [ Designated as safety issue: No ]
  • A composite endpoint of CV death, non fatal MI, and non fatal stroke [ Time Frame: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke, assessed up to Month 60 ] [ Designated as safety issue: No ]
  • A composite endpoint of all-cause death, non fatal MI, and non fatal stroke, and hospitalization for unstable angina needing urgent revascularization. [ Time Frame: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, and non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization, assessed up to M60 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Evaluation Of PF-04950615 (RN316) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of PF 04950615, In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

This study evaluates the PCSK9 inhibitor, PF-04950615 (RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).

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: Prevention
Cardiovascular Disease
  • Drug: PF-04950615
    150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
    Other Name: RN316
  • Drug: Placebo
    Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
  • Experimental: PF-04950615
    Intervention: Drug: PF-04950615
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6300
August 2017
August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be on background lipid lowering treatment.
  • Must be at high risk of a CV event.
  • Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).

Exclusion Criteria:

  • An LDL C <100 mg/dL (2.6 mmol/L) or non HDL C <130 mg/dL (3.4 mmol/L).
  • Planned coronary (PCI or CABG) or other arterial revascularization.
  • New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
  • Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis.
  • History of hemorrhagic stroke.
  • Prior exposure to PF 04950615 (RN316) or other investigational PCSK9 inhibitor.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Australia,   Belgium,   Canada,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Puerto Rico,   Romania,   Slovakia,   South Africa,   Spain,   Taiwan,   United Kingdom
 
NCT01975389
B1481038, CV OUTCOMES 2
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