A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

NCT01968980

Last updated date
Study Location
IMD Medical Group
Los Angeles, California, 90020, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heterozygous Familial Hypercholesterolemia
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

- 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.

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 of procedures during the past 30 days.


- Congestive heart failure NYHA class IV.


- Poorly controlled hypertension.

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Heterozygous Familial HypercholesterolemiaA 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
NCT01968980
  1. Los Angeles, California
  2. Hartford, Connecticut
  3. Hialeah, Florida
  4. Miami Beach, Florida
  5. Miami, Florida
  6. Miami, Florida
  7. Miami, Florida
  8. Las Vegas, Nevada
  9. Chapel Hill, North Carolina
  10. Chapel Hill, North Carolina
  11. Cincinnati, Ohio
  12. Oklahoma City, Oklahoma
  13. Oklahoma City, Oklahoma
  14. Oklahoma City, Oklahoma
  15. Philadelphia, Pennsylvania
  16. Gaffney, South Carolina
  17. Dallas, Texas
  18. Dallas, Texas
  19. Houston, Texas
  20. Sugar Land, Texas
  21. Draper, Utah
  22. Burke, Virginia
  23. Pleven,
  24. Plovdiv,
  25. Sofia,
  26. Sofia,
  27. Vancouver, British Columbia
  28. Victoria, British Columbia
  29. Winnipeg, Manitoba
  30. St. John's, Newfoundland and Labrador
  31. Ottawa, Ontario
  32. Chicoutimi, Quebec
  33. Montreal, Quebec
  34. Montreal, Quebec
  35. Quebec,
  36. Helsinki,
  37. Joensuu,
  38. Joensuu,
  39. Kerava,
  40. Oulu,
  41. Turku,
  42. Palermo, PA
  43. Perugia, PG
  44. Varese, VA
  45. Napoli,
  46. Goes, Zeeland
  47. Rotterdam, Zuid-holland
  48. Amsterdam,
  49. Breda,
  50. Den Haag,
  51. Deventer,
  52. Rotterdam,
  53. Sliedrecht,
  54. Utrecht,
  55. Oslo,
  56. Oslo,
  57. Bydgoszcz,
  58. Krakow,
  59. Ruda Slaska,
  60. Bloemfontein, Free State
  61. Centurion, Gauteng
  62. Halfway House, Gauteng
  63. Pretoria, Gauteng
  64. Pretoria, Gauteng
  65. Pretoria, Gauteng
  66. Roodepoort, Gauteng
  67. Durban, Kwa-zulu Natal
  68. Bellville, Cape Town, Western Cape
  69. Parow, Cape Town, Western Cape
  70. Somerset West, Western Cape
  71. L'Hospitalet de Llobregat, Barcelona
  72. Santiago de Compostela, Galicia
  73. Reus, Tarragona
  74. Barcelona,
  75. Cordoba,
  76. Madrid,
  77. Madrid,
  78. Madrid,
  79. Sevilla,
  80. Zaragoza,
  81. Manchester, Greater Manchester
  82. Oldham, Greater Manchester
  83. Stevenage, Hertfordshire
  84. Burton-on-Trent, Staffordshire
  85. Birmingham, West Midlands
  86. London,
  87. Manchester,
  88. Peterborough,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Drug: Bococizumab (PF-04950615;RN316)
    150 mg every 2 weeks, subcutaneous injection, 12 months
  • Other: Placebo
    subcutaneous injection every 2 weeks for 12 months
Study Arms  ICMJE
  • Experimental: Bococizumab (PF-04950615;RN316)
    Bococizumab (PF-04950615;RN316)
    Intervention: Drug: Bococizumab (PF-04950615;RN316)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
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
 (submitted: May 26, 2016)
370
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
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:

  • 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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