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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00134485
Other study ID # A5091026
Secondary ID
Status Completed
Phase Phase 3
First received August 22, 2005
Last updated October 28, 2007
Start date March 2005
Est. completion date March 2006

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 torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of Heterozygous Familial Hypercholesterolemia

- At least 18 years of age

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 (high doses)

- 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

Study Design

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


Intervention

Drug:
torcetrapib/atorvastatin

atorvastatin


Locations

Country Name City State
Australia Pfizer Investigational Site Camperdown New South Wales
Australia Pfizer Investigational Site Clayton Victoria
Australia Pfizer Investigational Site Darlinghurst
Australia Pfizer Investigational Site North Adelaide South Australia
Australia Pfizer Investigational Site Perth Western Australia
Australia Pfizer Investigational Site Woolloongabba Queensland
Canada Pfizer Investigational Site Chicoutimi Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Ste-Foy Quebec
Denmark Pfizer Investigational Site Aalborg
Denmark Pfizer Investigational Site Arhus C
France Pfizer Investigational Site Dijon
France Pfizer Investigational Site Nantes cedex 01
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Unknown Lille
Iceland Pfizer Investigational Site Kopavogur
Norway Pfizer Investigational Site Oslo
Norway Pfizer Investigational Site Oslo
South Africa Pfizer Investigational Site Bellville Western Cape
South Africa Pfizer Investigational Site Bloemfontein
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Parow Cape Town
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Linkoping
Sweden Pfizer Investigational Site Malmo
Sweden Pfizer Investigational Site Stockholm
United States Pfizer Investigational Site Auburn Maine
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Iowa City Iowa
United States Pfizer Investigational Site Lutz Florida
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Scarborough Maine
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tripler AMC Hawaii
United States Pfizer Investigational Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  France,  Iceland,  Norway,  South Africa,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HDL-C and LDL-C
Secondary Changes in other lipid parameters
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