Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00137462

Purpose

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

Condition	Intervention	Phase
Hyperlipidemia	Drug: torcetrapib/atorvastatin Drug: atorvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Atorvastatin Atorvastatin calcium Torcetrapib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Changes in levels of lipids and other biomarkers.

Estimated Enrollment:	900
Study Start Date:	November 2004
Estimated Study Completion Date:	September 2006

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137462

Show 59 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A5091019
Study First Received:	August 26, 2005
Last Updated:	November 15, 2007
ClinicalTrials.gov Identifier:	NCT00137462 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Torcetrapib
Therapeutic Uses
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010