You are viewing an expired study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials

Birmingham, Alabama

  • Diabetes Mellitus

Purpose:

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


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


Study is Available At:


Original ID:

A5091043


NCT ID:

NCT00134264


Secondary ID:


Study Acronym:

ILLUMINATE


Brief Title:

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


Official 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 Subjec


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

45 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

15067


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:July 2004
Completion Date:June 2007
Completion Type:Actual
Primary Completion Date:June 2007
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 30, 2012
First Received Date:August 22, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:The time to first occurrence of a major cardiovascular disease event
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Various composites of major cardiovascular disease events and other lipid parameters
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:torcetrapib/atorvastatin
Intervention Type:Drug
Name:atorvastatin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.