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 (A5091030)
| Verified date | April 2007 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 640 |
| Est. completion date | August 2006 |
| Est. primary completion date | |
| 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boynton Beach | Florida |
| United States | Pfizer Investigational Site | Butte | Montana |
| United States | Pfizer Investigational Site | Canton | Michigan |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Clinton | South Carolina |
| United States | Pfizer Investigational Site | Concord | New Hampshire |
| United States | Pfizer Investigational Site | Cooperstown | New York |
| United States | Pfizer Investigational Site | Cordova | Tennessee |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | East Syracuse | New York |
| United States | Pfizer Investigational Site | Fort Worth | Texas |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lincoln | Nebraska |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Madisonville | Kentucky |
| United States | Pfizer Investigational Site | Melbourne | Florida |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Merritt Island | Florida |
| United States | Pfizer Investigational Site | Mesa | Arizona |
| United States | Pfizer Investigational Site | Milan | Tennessee |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Mobile | Alabama |
| United States | Pfizer Investigational Site | Newton | Kansas |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| United States | Pfizer Investigational Site | Palm Bay | Florida |
| United States | Pfizer Investigational Site | Payson | Utah |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Portage | Michigan |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Safety Harbor | Florida |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Santa Rosa | California |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tempe | Arizona |
| United States | Pfizer Investigational Site | Topeka | Kansas |
| United States | Pfizer Investigational Site | Trenton | New Jersey |
| United States | Pfizer Investigational Site | Troy | Michigan |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| 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. |
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