Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia

NCT00134485

Last updated date
Study Location
Pfizer Investigational Site
San Diego, California, 92120, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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

- Diagnosis of Heterozygous Familial Hypercholesterolemia

- At least 18 years of age

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


- Women who are pregnant or lactating, or planning to become pregnant.


- Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor)
therapy other than atorvastatin or other concomitant therapy with known lipid altering
effects on LDL-C and HDL-C including fibrates and nicotinic acid (high doses)


- Subjects taking any drugs known to be associated with an increased risk of myositis in
combination with HMG-CoA reductase inhibitors


- Subjects with any other medical condition or laboratory abnormality which could affect
subject safety, preclude evaluation of response, or render unlikely that the subject
would complete the study

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Familial Hypercholesterolemia, HyperlipidemiaStudy To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
NCT00134485
  1. San Diego, California
  2. Washington, District of Columbia
  3. Lutz, Florida
  4. Tampa, Florida
  5. Tripler AMC, Hawaii
  6. Chicago, Illinois
  7. Indianapolis, Indiana
  8. Iowa City, Iowa
  9. Auburn, Maine
  10. Scarborough, Maine
  11. Boston, Massachusetts
  12. Charlotte, North Carolina
  13. Houston, Texas
  14. Madison, Wisconsin
  15. Camperdown, New South Wales
  16. Woolloongabba, Queensland
  17. North Adelaide, South Australia
  18. Clayton, Victoria
  19. Perth, Western Australia
  20. Darlinghurst,
  21. Chicoutimi, Quebec
  22. Montreal, Quebec
  23. Montreal, Quebec
  24. Ste-Foy, Quebec
  25. Aalborg,
  26. Arhus C,
  27. Dijon,
  28. Nantes cedex 01,
  29. Paris,
  30. Kopavogur,
  31. Oslo,
  32. Oslo,
  33. Parow, Cape Town
  34. Bellville, Western Cape
  35. Bloemfontein,
  36. Cape Town,
  37. Goteborg,
  38. Linkoping,
  39. Malmo,
  40. Stockholm,
ALL GENDERS
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
Official Title  ICMJE Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia
Brief Summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

Detailed Description For additional information please call: 1-800-718-1021
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia, Familial
  • Hyperlipidemia
Intervention  ICMJE
  • Drug: torcetrapib/atorvastatin
  • Drug: atorvastatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Enrollment  ICMJE
 (submitted: August 22, 2005)
400
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Heterozygous Familial Hypercholesterolemia
  • At least 18 years of age

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid (high doses)
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
  • Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study
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 Australia,   Canada,   Denmark,   France,   Iceland,   Norway,   South Africa,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00134485
Other Study ID Numbers  ICMJE A5091026
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP