Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00134511

Purpose

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

To evaluate the efficacy and safety of the lipid drug Torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol

Condition	Intervention	Phase
Hypercholesterolemia, Familial	Drug: Torcetrapib/atorvastatin	Phase III

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Torcetrapib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Multi-Center, Open Label, Forced Titration Study To Evaluate The Efficacy, Safety, And Tolerability Of Torcetrapib/Atorvastatin Combination Administered Orally, Once Daily (Qd) In Patients With Homozygous Familial Hypercholesterolaemia

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in LDL-C and HDL-C

Secondary Outcome Measures:

Other lipid variables

Estimated Enrollment:	30
Study Start Date:	March 2005
Estimated Study Completion Date:	November 2005

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:

Diagnosis of Homozygous Familial Hypercholesterolemia

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134511

Locations

United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Canada, Quebec
Pfizer Investigational Site
Chicoutimi, Quebec, Canada, G7H 5H6
Pfizer Investigational Site
Ste-Foy, Quebec, Canada, G1V 4M6
South Africa
Pfizer Investigational Site
Bloemfontein, South Africa, 9301
Pfizer Investigational Site
Cape Town, South Africa, 7925
South Africa, Johannesburg
Pfizer Investigational Site
Parktown, Johannesburg, South Africa, 2193

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:	A5091027
Study First Received:	August 22, 2005
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00134511 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Hyperlipoproteinemia Type II
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolism, Inborn Errors

Genetic Diseases, Inborn
Torcetrapib
Hypercholesterolemia, Autosomal Dominant
Hypercholesterolemia
Metabolic Disorder
Hyperlipoproteinemias
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Hyperlipoproteinemia Type II
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Torcetrapib
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009