Dyslipidemia Clinical Trial
Official title:
Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects With Dyslipidemia.
| Verified date | December 2006 |
| 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 combination cholesterol medications to see how the different treatments
compare to one another.
| Status | Terminated |
| Enrollment | 1784 |
| Est. completion date | January 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Specific LDL-C levels based on CHD risk after a six-week washout period. 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 requiring systemic steroids - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Anaheim | California |
| United States | Pfizer Investigational Site | Anderson | South Carolina |
| United States | Pfizer Investigational Site | Arlington | Texas |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Atlantis | Florida |
| United States | Pfizer Investigational Site | Aurora | Illinois |
| United States | Pfizer Investigational Site | Ayer | Massachusetts |
| United States | Pfizer Investigational Site | Beaver | Pennsylvania |
| United States | Pfizer Investigational Site | Bensalem | Pennsylvania |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Bloomfield Hills | Michigan |
| United States | Pfizer Investigational Site | Boca Raton | Florida |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Bountiful | Utah |
| United States | Pfizer Investigational Site | Bristol | Tennessee |
| United States | Pfizer Investigational Site | Brooklyn Center | Minnesota |
| United States | Pfizer Investigational Site | Cary | North Carolina |
| United States | Pfizer Investigational Site | Chandler | Arizona |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Chattanooga | Tennessee |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Columbia | Missouri |
| United States | Pfizer Investigational Site | Columbia | Maryland |
| United States | Pfizer Investigational Site | Cooperstown | New York |
| United States | Pfizer Investigational Site | Daytona Beach | Florida |
| United States | Pfizer Investigational Site | DeFuniak Springs | Florida |
| United States | Pfizer Investigational Site | Des Moines | Iowa |
| United States | Pfizer Investigational Site | Destin | Florida |
| United States | Pfizer Investigational Site | Doylestown | Pennsylvania |
| United States | Pfizer Investigational Site | Edgewood | Kentucky |
| United States | Pfizer Investigational Site | Edina | Minnesota |
| United States | Pfizer Investigational Site | Endwell | New York |
| United States | Pfizer Investigational Site | Erlanger | Kentucky |
| United States | Pfizer Investigational Site | Escondido | California |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Fairview Park | Ohio |
| United States | Pfizer Investigational Site | Fresno | California |
| United States | Pfizer Investigational Site | Germantown | Tennessee |
| United States | Pfizer Investigational Site | Golden | Colorado |
| United States | Pfizer Investigational Site | Grand Rapids | Michigan |
| United States | Pfizer Investigational Site | Harleysville | Pennsylvania |
| United States | Pfizer Investigational Site | Honolulu | Hawaii |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Huntersville | North Carolina |
| United States | Pfizer Investigational Site | Jefferson City | Missouri |
| United States | Pfizer Investigational Site | Johnson City | Tennessee |
| United States | Pfizer Investigational Site | Jonesboro | Arkansas |
| United States | Pfizer Investigational Site | Lakeland | Florida |
| United States | Pfizer Investigational Site | Lancaster | Pennsylvania |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lewiston | New York |
| United States | Pfizer Investigational Site | Lincoln | Rhode Island |
| United States | Pfizer Investigational Site | Los Altos | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Manchester | Missouri |
| United States | Pfizer Investigational Site | Manlius | New York |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Mesa | Arizona |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Milford | Massachusetts |
| United States | Pfizer Investigational Site | Monroe | North Carolina |
| United States | Pfizer Investigational Site | Mount Pleasant | South Carolina |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | Newark | Delaware |
| United States | Pfizer Investigational Site | Newport News | Virginia |
| United States | Pfizer Investigational Site | Newton | Kansas |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Orlando | Florida |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Palm Springs | California |
| United States | Pfizer Investigational Site | Paramount | California |
| United States | Pfizer Investigational Site | Pensacola | Florida |
| United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
| United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
| United States | Pfizer Investigational Site | Pratt | Kansas |
| United States | Pfizer Investigational Site | Providence | Rhode Island |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Renton | Washington |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Rockford | Illinois |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Santa Rose | California |
| United States | Pfizer Investigational Site | Sayre | Pennsylvania |
| United States | Pfizer Investigational Site | Selmer | Tennessee |
| United States | Pfizer Investigational Site | Simpsonville | South Carolina |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Springfield | Illinois |
| United States | Pfizer Investigational Site | Springfield | Missouri |
| United States | Pfizer Investigational Site | Springfield | Missouri |
| United States | Pfizer Investigational Site | St. Cloud | Minnesota |
| United States | Pfizer Investigational Site | Syracuse | New York |
| United States | Pfizer Investigational Site | Topeka | Kansas |
| United States | Pfizer Investigational Site | Troy | Michigan |
| United States | Pfizer Investigational Site | Walnut Creek | California |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | West Seneca | New York |
| United States | Pfizer Investigational Site | Westlake Village | California |
| United States | Pfizer Investigational Site | Wilmington | North Carolina |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| 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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