A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00267280
First received: December 19, 2005
Last updated: February 15, 2012
Last verified: February 2012

December 19, 2005
February 15, 2012
January 2006
December 2006   (final data collection date for primary outcome measure)
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
Same as current
Complete list of historical versions of study NCT00267280 on ClinicalTrials.gov Archive Site
Changes in other lipid parameters and other biomarkers.
Same as current
Not Provided
Not Provided
 
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).
A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091031)

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

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

For additional information please call: 1-800-718-1021

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperlipidemia
  • Dyslipidemia
  • Hypercholesterolemia
  • Drug: torcetrapib/atorvastatin
  • Drug: simvastatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
640
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
  • Subjects with significant liver or kidney disease or significant heart failure.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00267280
A5091031
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

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