Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00137462

First received: August 26, 2005

Last updated: November 15, 2007

Last verified: December 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

August 26, 2005

Last Updated Date

November 15, 2007

Start Date ^ICMJE

November 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.

Original Primary Outcome Measures ^ICMJE

Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.

Change History

Complete list of historical versions of study NCT00137462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in levels of lipids and other biomarkers.

Original Secondary Outcome Measures ^ICMJE

Changes in levels of lipids and other biomarkers.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.

Official Title ^ICMJE

A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias

Brief Summary

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

To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Hyperlipidemia

Intervention ^ICMJE

Drug: torcetrapib/atorvastatin
Drug: atorvastatin

Study Arm (s)

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

Completed

Enrollment ^ICMJE

900

Completion Date

September 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Statin eligible per NCEP ATP-III guidelines
At least 18 years of age

Exclusion Criteria:

Women who are pregnant or lactating, or planning to become pregnant
Intolerance to statin therapy
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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00137462

Other Study ID Numbers ^ICMJE

A5091019

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

December 2006

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

To Top