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

Hypercholesterolemia, Familial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134511
• Other study ID #: A5091027
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: November 5, 2007
• Start date: March 2005
• Est. completion date: November 2005

Study information

• Verified date: December 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypercholesterolemia, Familial
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Torcetrapib/atorvastatin

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	Ste-Foy	Quebec
South Africa	Pfizer Investigational Site	Bloemfontein
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Parktown	Johannesburg
United States	Pfizer Investigational Site	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL-C and HDL-C
Secondary	Other lipid variables