A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
NCT01968980
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- Heterozygous familial hypercholesterolemia.
- Pregnant or breastfeeding females.
- Cardiovascular or cerebrovascular event of procedures during the past 30 days.
- Congestive heart failure NYHA class IV.
- Poorly controlled hypertension.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Los Angeles, California
- Hartford, Connecticut
- Hialeah, Florida
- Miami Beach, Florida
- Miami, Florida
- Miami, Florida
- Miami, Florida
- Las Vegas, Nevada
- Chapel Hill, North Carolina
- Chapel Hill, North Carolina
- Cincinnati, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Philadelphia, Pennsylvania
- Gaffney, South Carolina
- Dallas, Texas
- Dallas, Texas
- Houston, Texas
- Sugar Land, Texas
- Draper, Utah
- Burke, Virginia
- Pleven,
- Plovdiv,
- Sofia,
- Sofia,
- Vancouver, British Columbia
- Victoria, British Columbia
- Winnipeg, Manitoba
- St. John's, Newfoundland and Labrador
- Ottawa, Ontario
- Chicoutimi, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Quebec,
- Helsinki,
- Joensuu,
- Joensuu,
- Kerava,
- Oulu,
- Turku,
- Palermo, PA
- Perugia, PG
- Varese, VA
- Napoli,
- Goes, Zeeland
- Rotterdam, Zuid-holland
- Amsterdam,
- Breda,
- Den Haag,
- Deventer,
- Rotterdam,
- Sliedrecht,
- Utrecht,
- Oslo,
- Oslo,
- Bydgoszcz,
- Krakow,
- Ruda Slaska,
- Bloemfontein, Free State
- Centurion, Gauteng
- Halfway House, Gauteng
- Pretoria, Gauteng
- Pretoria, Gauteng
- Pretoria, Gauteng
- Roodepoort, Gauteng
- Durban, Kwa-zulu Natal
- Bellville, Cape Town, Western Cape
- Parow, Cape Town, Western Cape
- Somerset West, Western Cape
- L'Hospitalet de Llobregat, Barcelona
- Santiago de Compostela, Galicia
- Reus, Tarragona
- Barcelona,
- Cordoba,
- Madrid,
- Madrid,
- Madrid,
- Sevilla,
- Zaragoza,
- Manchester, Greater Manchester
- Oldham, Greater Manchester
- Stevenage, Hertfordshire
- Burton-on-Trent, Staffordshire
- Birmingham, West Midlands
- London,
- Manchester,
- Peterborough,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia | |||
Official Title ICMJE | A 52 Week, Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia | |||
Brief Summary | This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Heterozygous Familial Hypercholesterolemia | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 370 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | April 15, 2016 | |||
Actual Primary Completion Date | April 15, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Bulgaria, Canada, Finland, Italy, Netherlands, Norway, Poland, South Africa, Spain, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01968980 | |||
Other Study ID Numbers ICMJE | B1481021 2013-002644-87 ( EudraCT Number ) SPIRE-HF ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |