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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Creekside Endocrine Associates, PC
Denver, Colorado, 80209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hyperlipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Hyperlipidemia

- Statin Intolerant

- Fasting LDL-C > = 70 mg/dL Fasting TG

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnant or breastfeeding females

- Cardiovascular or cerebrovascular event or procedure within 90 days

- Severe or life-threatening adverse events with past use of statins

- Poorly controlled hypertension

NCT02135029
Pfizer
Completed
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins
This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Drug: Bococizumab (PF-04950615;RN316)
    150 mg every 2 weeks by subcutaneous injection for 24 weeks
  • Drug: Atorvastatin
    Atorvastatin PO QD
  • Other: Placebo for Bococizumab (PF-04950615;RN316)
    150 mg every 2 weeks by subcutaneous injection for 24 weeks
  • Other: Placebo for atorvastatin
    PO QD
  • Experimental: Bococizumab (PF-04950615;RN316)
    Bococizumab (PF-04950615;RN316)
    Intervention: Drug: Bococizumab (PF-04950615;RN316)
  • Active Comparator: Atorvastatin
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Placebo
    Interventions:
    • Other: Placebo for Bococizumab (PF-04950615;RN316)
    • Other: Placebo for atorvastatin
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
November 2015
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hyperlipidemia
  • Statin Intolerant
  • Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Cardiovascular or cerebrovascular event or procedure within 90 days
  • Severe or life-threatening adverse events with past use of statins
  • Poorly controlled hypertension
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT02135029
B1481030
STATIN INTOLERANT
SPIRE-SI ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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