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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00134264
• Date of registration: 22/08/2005
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease ILLUMINATE
• Scientific title: 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
• Date of first enrolment: July 2004
• Target sample size: 15067
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00134264
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Netherlands, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 45 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Disease

Diabetes Mellitus

Intervention(s)

Drug: torcetrapib/atorvastatin

Drug: atorvastatin

Primary Outcome(s)

The time to first occurrence of a major cardiovascular disease event

Secondary Outcome(s)

Various composites of major cardiovascular disease events and other lipid parameters

Secondary ID(s)

A5091043

Source(s) of Monetary Support

Please refer to primary and secondary sponsors