A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

Hypercholesterolemia Clinical Trial

Official title:

A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091031)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00267280
• Other study ID #: A5091031
• Status: Terminated
• Phase: Phase 3
• First received: December 19, 2005
• Last updated: February 15, 2012
• Start date: January 2006
• Est. completion date: December 2006

Study information

• Verified date: February 2012
• 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.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 640
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria:

• Women who are pregnant or lactating, or planning to become pregnant.

• Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.

• Subjects with significant liver or kidney disease or significant heart failure.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• torcetrapib/atorvastatin

• simvastatin

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Alhambra	California
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Beaver	Pennsylvania
United States	Pfizer Investigational Site	Bellevue	Washington
United States	Pfizer Investigational Site	Bethesda	Maryland
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Collierville	Tennessee
United States	Pfizer Investigational Site	Conyers	Georgia
United States	Pfizer Investigational Site	Elkton	Maryland
United States	Pfizer Investigational Site	Flint	Michigan
United States	Pfizer Investigational Site	Flourtown	Pennsylvania
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Hillsboro	Oregon
United States	Pfizer Investigational Site	Hinsdale	Illinois
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Inglewood	California
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	La Grange	Illinois
United States	Pfizer Investigational Site	Lawrenceville	New Jersey
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Mansfield	Ohio
United States	Pfizer Investigational Site	Merritt Island	Florida
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	North Richland Hills	Texas
United States	Pfizer Investigational Site	Park Ridge	Illinois
United States	Pfizer Investigational Site	Pensacola	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Puyallup	Washington
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Santa Ana	California
United States	Pfizer Investigational Site	Seaford	New York
United States	Pfizer Investigational Site	Spring	Texas
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Vero Beach	Florida
United States	Pfizer Investigational Site	West Jordan	Utah
United States	Pfizer Investigational Site	Wilmington	Delaware
United States	Pfizer Investigational Site	Winter Park	Florida
United States	Pfizer Investigational Site	Woodstock	Georgia
United States	Pfizer Investigational Site	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
Secondary	Changes in other lipid parameters and other biomarkers.