Hyperlipidemia Clinical Trial
Official title:
A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).
| Verified date | February 2012 |
| 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.
A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or
placebo.
| Status | Completed |
| Enrollment | 3800 |
| Est. completion date | August 2006 |
| Est. primary completion date | August 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - subjects with elevated cholesterol Exclusion Criteria: - Women who are pregnant or lactating, or planning to become pregnant. - Intolerance to statin therapy resulting in withdrawal - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Dottignies | |
| Belgium | Pfizer Investigational Site | Ham | |
| Belgium | Pfizer Investigational Site | Hasselt | |
| Belgium | Pfizer Investigational Site | Hoeilaart | |
| Belgium | Pfizer Investigational Site | La Louviere | |
| Belgium | Pfizer Investigational Site | Leuven | |
| Belgium | Pfizer Investigational Site | Wilsele | |
| Germany | Pfizer Investigational Site | Beckum | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Bochum | |
| Germany | Pfizer Investigational Site | Erlangen | |
| Germany | Pfizer Investigational Site | Essen | |
| Germany | Pfizer Investigational Site | Feldafing | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Heidelberg | |
| Germany | Pfizer Investigational Site | Homburg/Saar | |
| Germany | Pfizer Investigational Site | Karlsruhe | |
| Germany | Pfizer Investigational Site | Kuenzing | |
| Germany | Pfizer Investigational Site | Nuernberg | |
| Germany | Pfizer Investigational Site | Offenbach | |
| Germany | Pfizer Investigational Site | Rodgau | |
| Germany | Pfizer Investigational Site | Schwerin | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Korea, Republic of | Pfizer Investigational Site | Suwon | |
| Mexico | Pfizer Investigational Site | Mexico | D.f. |
| Mexico | Pfizer Investigational Site | Mexico | DF |
| Mexico | Pfizer Investigational Site | Monterrey | Nuevo Leon |
| Mexico | Pfizer Investigational Site | Puebla | |
| Mexico | Pfizer Investigational Site | Tlalpan | D.f. |
| Norway | Pfizer Investigational Site | Bekkestua | |
| Norway | Pfizer Investigational Site | Elverum | |
| Norway | Pfizer Investigational Site | Honefoss | |
| Norway | Pfizer Investigational Site | Jessheim | |
| Norway | Pfizer Investigational Site | Kongsberg | |
| Norway | Pfizer Investigational Site | Lena | |
| Norway | Pfizer Investigational Site | Lierskogen | |
| Norway | Pfizer Investigational Site | Molde | |
| Norway | Pfizer Investigational Site | Moss | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Roverud | |
| Norway | Pfizer Investigational Site | Skedsmokorset | |
| Norway | Pfizer Investigational Site | Tromso | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Jarfalla | |
| Sweden | Pfizer Investigational Site | Linkoping | |
| Sweden | Pfizer Investigational Site | Orebro | |
| Sweden | Pfizer Investigational Site | Strangnas | |
| Sweden | Pfizer Investigational Site | Umea | |
| United Kingdom | Pfizer Investigational Site | Addlestone | Surrey |
| United Kingdom | Pfizer Investigational Site | Blackpool | Lancashire |
| United Kingdom | Pfizer Investigational Site | Blackpool | Lancs. Fy3 7dq |
| United Kingdom | Pfizer Investigational Site | East Horsley, Leatherhead | Surrey |
| United Kingdom | Pfizer Investigational Site | Garston | Hertfordshire |
| United Kingdom | Pfizer Investigational Site | Middlesex | Harrow |
| United Kingdom | Pfizer Investigational Site | Penzance | Cornwall |
| United Kingdom | Pfizer Investigational Site | Warminster | Wiltshire |
| United Kingdom | Pfizer Investigational Site | Woolwell, Plymouth | Devon |
| United States | Pfizer Investigational Site | Anaheim | California |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Beaumont | Texas |
| United States | Pfizer Investigational Site | Beaverton | Oregon |
| United States | Pfizer Investigational Site | Bethesda | Maryland |
| United States | Pfizer Investigational Site | Billings | Montana |
| United States | Pfizer Investigational Site | Boulder | Colorado |
| United States | Pfizer Investigational Site | Bryan | Texas |
| United States | Pfizer Investigational Site | Carmichael | California |
| 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 | Concord | North Carolina |
| United States | Pfizer Investigational Site | Concord | California |
| United States | Pfizer Investigational Site | Coral Gables | Florida |
| United States | Pfizer Investigational Site | Covington | Louisiana |
| United States | Pfizer Investigational Site | Creve Coevr | Illinois |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Elkton | Maryland |
| United States | Pfizer Investigational Site | Elyria | Ohio |
| United States | Pfizer Investigational Site | Endwell | New York |
| United States | Pfizer Investigational Site | Erlanger | Kentucky |
| United States | Pfizer Investigational Site | Fayetteville | North Carolina |
| United States | Pfizer Investigational Site | Ft. Pierce | Florida |
| United States | Pfizer Investigational Site | Greenbrae | California |
| United States | Pfizer Investigational Site | Greer | South Carolina |
| United States | Pfizer Investigational Site | Hillsboro | Oregon |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Iowa City | Iowa |
| United States | Pfizer Investigational Site | Jackson | Mississippi |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jefferson City | Missouri |
| United States | Pfizer Investigational Site | Jupiter | Florida |
| United States | Pfizer Investigational Site | Kansas City | Kansas |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kingsport | Tennessee |
| United States | Pfizer Investigational Site | Lake Success | New York |
| United States | Pfizer Investigational Site | Lake Worth | Florida |
| 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 | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Melbourne | Florida |
| United States | Pfizer Investigational Site | Mesa | Arizona |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Mission Viejo | California |
| United States | Pfizer Investigational Site | Mobile | Alabama |
| United States | Pfizer Investigational Site | Monroe | North Carolina |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | Newark | Delaware |
| United States | Pfizer Investigational Site | Newport News | Virginia |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| United States | Pfizer Investigational Site | Olmsted Township | Ohio |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Oregon | Wisconsin |
| United States | Pfizer Investigational Site | Oro Valley | Arizona |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Palm Bay | Florida |
| United States | Pfizer Investigational Site | Peoria | Illinois |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Renton | Washington |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Rockford | Illinois |
| United States | Pfizer Investigational Site | Sacramento | California |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Santa Ana | California |
| United States | Pfizer Investigational Site | Scarborough | Maine |
| United States | Pfizer Investigational Site | Sebastian | Florida |
| United States | Pfizer Investigational Site | Slidell | Louisiana |
| United States | Pfizer Investigational Site | Spartanburg | South Carolina |
| United States | Pfizer Investigational Site | Stockton | California |
| United States | Pfizer Investigational Site | Stuart | Florida |
| United States | Pfizer Investigational Site | Sun City | Arizona |
| United States | Pfizer Investigational Site | The Colony | Texas |
| United States | Pfizer Investigational Site | Thouasand Oaks | California |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tustin | California |
| United States | Pfizer Investigational Site | Upland | California |
| United States | Pfizer Investigational Site | Vero Beach | Florida |
| United States | Pfizer Investigational Site | Walnut Creek | California |
| United States | Pfizer Investigational Site | Warwick | Rhode Island |
| United States | Pfizer Investigational Site | Waterbury | Connecticut |
| United States | Pfizer Investigational Site | Wellington | Florida |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | Westlake | Ohio |
| United States | Pfizer Investigational Site | Westlake Village | California |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Williamsville | New York |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| United States | Pfizer Investigational Site | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Belgium, Germany, Korea, Republic of, Mexico, Norway, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | LDL and HDL levels | |||
| Secondary | other lipid parameters |
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