A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease (ILLUMINATE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00134264
First received: August 22, 2005
Last updated: January 30, 2012
Last verified: January 2012

August 22, 2005
January 30, 2012
July 2004
June 2007   (final data collection date for primary outcome measure)
The time to first occurrence of a major cardiovascular disease event
Same as current
Complete list of historical versions of study NCT00134264 on ClinicalTrials.gov Archive Site
Various composites of major cardiovascular disease events and other lipid parameters
Same as current
Not Provided
Not Provided
 
A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease
Phase 3 Multi Center, Double Blind, Randomized, Parallel Group Evaluation Of The Fixed Combination Torcetrapib/Atorvastatin, Administered Orally, Once Daily (Qd), Compared With Atorvastatin Alone, On The Occurrence Of Major Cardiovascular Events In Subjects With Coronary Heart Disease Or Risk Equivalents

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

To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Coronary Disease
  • Diabetes Mellitus
  • Drug: torcetrapib/atorvastatin
  • Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15067
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events

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 evaluationof response, or render unlikely that the subject would complete the study
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   Spain,   Sweden,   United Kingdom
 
NCT00134264
A5091043
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

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