You are here

Our science / Clinical Trials / Find a Trial / NCT02135029

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

Back to Search Print Save as PDF Bookmark Trial

NCT02135029

Last updated on December 6, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Creekside Endocrine Associates, PC
Denver, Colorado, 80209 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Hyperlipidemia
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
NCT02135029
All Genders
18+
Years
Multiple Sites
Familial Hypercholesterolemia, Hyperlipidemia
Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
NCT00136981
All Genders
18+
Years
Multiple Sites
Hyperlipidemia
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
NCT01968954
All Genders
18+
Years
Multiple Sites
Hyperlipidemia, Dyslipidemia
A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.
NCT00267267
All Genders
18+
Years
Multiple Sites
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now