A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

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NCT00134498

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Study Location
Pfizer Investigational Site
Anaheim, California, , United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertriglyceridemia, Hyperlipoproteinemia Type IV
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 Fredrickson Type IV Hypertriglyceridemia

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


- 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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Hypertriglyceridemia, Hyperlipoproteinemia Type IVA Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides NCT00134498
  1. Anaheim, California
  2. Huntington Beach, California
  3. Los Angeles, California
  4. Orangevale, California
  5. Orange, California
  6. Pacific Palisades, California
  7. Studio City, California
  8. Tustin, California
  9. Walnut Creek, California
  10. Farmington, Connecticut
  11. Washington, District of Columbia
  12. Hollywood, Florida
  13. Longwood, Florida
  14. West Palm Beach, Florida
  15. Tripler AMC, Hawaii
  16. Chicago, Illinois
  17. Indianapolis, Indiana
  18. Overland Park, Kansas
  19. Baton Rouge, Louisiana
  20. Scarborough, Maine
  21. Bethesda, Maryland
  22. Ann Arbor, Michigan
  23. Canton, Michigan
  24. Portage, Michigan
  25. Richland, Michigan
  26. St. Cloud, Minnesota
  27. Olive Branch, Mississippi
  28. Jefferson City, Missouri
  29. St. Louis, Missouri
  30. Las Vegas, Nevada
  31. Rochester, New York
  32. Syracuse, New York
  33. West Seneca, New York
  34. Statesville, North Carolina
  35. Sellersville, Pennsylvania
  36. Warwick, Rhode Island
  37. San Antonio, Texas
  38. Richmond, Virginia
  39. Madison, Wisconsin
  40. Halifax, Nova Scotia
  41. London, Ontario
  42. Chicoutimi, Quebec
  43. Montreal, Quebec
  44. Ste-Foy, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides
Official Title  ICMJE Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia
Brief Summary

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

To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

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
  • Hypertriglyceridemia
  • Hyperlipoproteinemia Type IV
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)		160
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Fredrickson Type IV Hypertriglyceridemia

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
  • 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00134498
Other Study ID Numbers  ICMJE A5091025
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 March 2007

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