Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.

NCT00145431

Last updated date
Study Location
Pfizer Investigational Site
Anaheim, California, 92804, 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:

By phone

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.
Hyperlipoproteinemia Type III
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 Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)

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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[email protected]

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Hyperlipoproteinemia Type IIIStudy To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder. NCT00145431
  1. Anaheim, California
  2. Huntington Beach, California
  3. Orange, California
  4. Pacific Palisades, California
  5. Studio City, California
  6. Tustin, California
  7. Hollywood, Florida
  8. Longwood, Florida
  9. Tripler Army Medical Center, Hawaii
  10. Scarborough, Maine
  11. Portage, Michigan
  12. Portage, Michigan
  13. Olive Branch, Mississippi
  14. Rochester, New York
  15. Syracuse, New York
  16. West Seneca, New York
  17. Sellersville, Pennsylvania
  18. Greer, South Carolina
  19. Memphis, Tennessee
  20. Salt Lake City, Utah
  21. Seattle, Washington
  22. Madison, Wisconsin
  23. London, Ontario
  24. Chicoutimi, Quebec
  25. Montreal, Quebec
  26. Montreal, Quebec
  27. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.
Official Title  ICMJE Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).
Brief Summary

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

To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.

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: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hyperlipoproteinemia Type III
Intervention  ICMJE
  • Drug: torcetrapib/atorvastatin
  • Drug: atorvastatin
  • Drug: fenofibrate
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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 15, 2012)
41
Original Enrollment  ICMJE
 (submitted: August 31, 2005)
84
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)

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 NCT00145431
Other Study ID Numbers  ICMJE A5091024
Has Data Monitoring Committee Not Provided
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 February 2012

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