Cardiovascular Disease Clinical Trial
— TNTOfficial title:
The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD
| Verified date | May 2007 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.
| Status | Completed |
| Enrollment | 8600 |
| Est. completion date | August 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 75 Years |
| Eligibility |
Inclusion Criteria: Men and women age 35-75 who have evident CHD Exclusion Criteria: Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | Adelaide | South Australia |
| Australia | Pfizer Investigational Site | Auchenflower | Queensland |
| Australia | Pfizer Investigational Site | Bedford Park | South Australia |
| Australia | Pfizer Investigational Site | Brisbane | Queensland |
| Australia | Pfizer Investigational Site | Chermside | Queensland |
| Australia | Pfizer Investigational Site | Clayton | Victoria |
| Australia | Pfizer Investigational Site | Greenslopes | Queensland |
| Australia | Pfizer Investigational Site | Herston | Queensland |
| Australia | Pfizer Investigational Site | Hobart | Tasmania |
| Australia | Pfizer Investigational Site | Milton | Queensland |
| Australia | Pfizer Investigational Site | Nedlands | Western Australia |
| Australia | Pfizer Investigational Site | Parkville | Victoria |
| Australia | Pfizer Investigational Site | Prahran | Victoria |
| Australia | Pfizer Investigational Site | St. Leonards | New South Wales |
| Austria | Pfizer Investigational Site | Feldkirch | |
| Austria | Pfizer Investigational Site | Oberpullendorf | |
| Austria | Pfizer Investigational Site | Wien | |
| Austria | Pfizer Investigational Site | Wien | |
| Belgium | Pfizer Investigational Site | Aalst | |
| Belgium | Pfizer Investigational Site | Antwerpen | |
| Belgium | Pfizer Investigational Site | Genk | |
| Belgium | Pfizer Investigational Site | Genk | |
| Belgium | Pfizer Investigational Site | Godinne | |
| Belgium | Pfizer Investigational Site | Leuven | |
| Belgium | Pfizer Investigational Site | Lommel | |
| Belgium | Pfizer Investigational Site | Neerpelt | |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Chicoutimi | Quebec |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | Hamilton | Ontario |
| Canada | Pfizer Investigational Site | London | Ontario |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Nanaimo | British Columbia |
| Canada | Pfizer Investigational Site | Ottawa | Ontario |
| Canada | Pfizer Investigational Site | Quebec | |
| Canada | Pfizer Investigational Site | Sherbrooke | Quebec |
| Canada | Pfizer Investigational Site | St-foy | Quebec |
| Canada | Pfizer Investigational Site | St. John's | Newfoundland and Labrador |
| Canada | Pfizer Investigational Site | Sudbury | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Victoria | British Columbia |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| France | Pfizer Investigational Site | Agen | |
| France | Pfizer Investigational Site | Bordeaux | |
| France | Pfizer Investigational Site | Brest | |
| France | Pfizer Investigational Site | Clermont-ferrand | |
| France | Pfizer Investigational Site | Lyon | |
| France | Pfizer Investigational Site | Marseille | |
| France | Pfizer Investigational Site | Paris CEDEX 05 | |
| France | Pfizer Investigational Site | Pessac | Cedex |
| France | Pfizer Investigational Site | Rennes | |
| France | Pfizer Investigational Site | Roubaix Cdx | |
| France | Pfizer Investigational Site | Strasbourg | |
| France | Pfizer Investigational Site | Toulouse | |
| France | Pfizer Investigational Site | Toulouse | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Essen | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Schwerte | |
| Germany | Pfizer Investigational Site | Tostedt | |
| Germany | Pfizer Investigational Site | Wurzburg | |
| Ireland | Pfizer Investigational Site | Cork | |
| Ireland | Pfizer Investigational Site | Dublin | |
| Italy | Pfizer Investigational Site | Bologna | |
| Italy | Pfizer Investigational Site | Bologna | |
| Italy | Pfizer Investigational Site | Cuneo | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Napoli | |
| Italy | Pfizer Investigational Site | Rome | |
| Italy | Pfizer Investigational Site | Udine | |
| Netherlands | Pfizer Investigational Site | 's-Hertogenbosch | |
| Netherlands | Pfizer Investigational Site | Alkmaar | |
| Netherlands | Pfizer Investigational Site | Amersfoort | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Eindhoven | |
| Netherlands | Pfizer Investigational Site | Enschede | |
| Netherlands | Pfizer Investigational Site | Groningen | |
| Netherlands | Pfizer Investigational Site | Groningen | |
| Netherlands | Pfizer Investigational Site | Leiden | |
| Netherlands | Pfizer Investigational Site | Nieuwegein | |
| Netherlands | Pfizer Investigational Site | Nijmegen | |
| Netherlands | Pfizer Investigational Site | Zwolle | |
| Netherlands | Pfizer Investigational Site | Zwolle | |
| South Africa | Pfizer Investigational Site | Bloemfontein | |
| South Africa | Pfizer Investigational Site | Cape Town | |
| South Africa | Pfizer Investigational Site | Cape Town | |
| South Africa | Pfizer Investigational Site | Johannesburg | Gauteng |
| South Africa | Pfizer Investigational Site | Parow | |
| South Africa | Pfizer Investigational Site | Sunninghill | Gauteng |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Cordoba | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | San Sebastian | |
| Spain | Pfizer Investigational Site | Santiago de Compostela | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Unknown | Madrid |
| Spain | Pfizer Investigational Site | Valladolid | |
| Spain | Pfizer Investigational Site | Zaragoza | |
| Switzerland | Pfizer Investigational Site | Bern | |
| Switzerland | Pfizer Investigational Site | Geneve 14 | |
| Switzerland | Pfizer Investigational Site | Lausanne | |
| Switzerland | Pfizer Investigational Site | Lugano | |
| Switzerland | Pfizer Investigational Site | St Gallen | |
| United Kingdom | Pfizer Investigational Site | Aldershot | Hampshire |
| United Kingdom | Pfizer Investigational Site | Barnet | |
| United Kingdom | Pfizer Investigational Site | Blackpool | Lancashire |
| United Kingdom | Pfizer Investigational Site | Coventry | West Midlands |
| United Kingdom | Pfizer Investigational Site | Coventry | West Midlands |
| United Kingdom | Pfizer Investigational Site | Farnborough | Kent |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Leicester | Leicestershire |
| United Kingdom | Pfizer Investigational Site | London | Middlesex |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | Greater London |
| United Kingdom | Pfizer Investigational Site | London | Greater London |
| United Kingdom | Pfizer Investigational Site | London | Greater London |
| United Kingdom | Pfizer Investigational Site | Paisley | |
| United Kingdom | Pfizer Investigational Site | Romford | Essex |
| United Kingdom | Pfizer Investigational Site | Swindon | Wiltshire |
| United States | Pfizer Investigational Site | Alabaster | Alabama |
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Allentown | Pennsylvania |
| United States | Pfizer Investigational Site | Allentown | Pennsylvania |
| United States | Pfizer Investigational Site | Asheville | North Carolina |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Aurora | Colorado |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Beachwood | Ohio |
| United States | Pfizer Investigational Site | Beech Grove | Indiana |
| United States | Pfizer Investigational Site | Bel Air | Maryland |
| United States | Pfizer Investigational Site | Berwyn | Illinois |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Blue Island | Illinois |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Bridgeport | Connecticut |
| United States | Pfizer Investigational Site | Brooklyn | New York |
| United States | Pfizer Investigational Site | Burbank | California |
| United States | Pfizer Investigational Site | Burlington | Massachusetts |
| United States | Pfizer Investigational Site | Burlington | Vermont |
| United States | Pfizer Investigational Site | Camp Pendleton | California |
| United States | Pfizer Investigational Site | Canton | Georgia |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Clearwater | Florida |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dearborn | Michigan |
| United States | Pfizer Investigational Site | Denton | Texas |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Des Moines | Iowa |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Duluth | Minnesota |
| United States | Pfizer Investigational Site | DuQuoin | Illinois |
| United States | Pfizer Investigational Site | Durham | North Carolina |
| United States | Pfizer Investigational Site | Eden | North Carolina |
| United States | Pfizer Investigational Site | Edgewood | Kentucky |
| United States | Pfizer Investigational Site | Edina | Minnesota |
| United States | Pfizer Investigational Site | Erlanger | Kentucky |
| United States | Pfizer Investigational Site | Eugene | Oregon |
| United States | Pfizer Investigational Site | Evanston | Illinois |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Farmington Hill | Michigan |
| United States | Pfizer Investigational Site | Fort Wayne | Indiana |
| United States | Pfizer Investigational Site | Fort Wayne | Indiana |
| United States | Pfizer Investigational Site | Fresno | California |
| United States | Pfizer Investigational Site | Gainsville | Florida |
| United States | Pfizer Investigational Site | Gainsville | Florida |
| United States | Pfizer Investigational Site | Hartford | Connecticut |
| United States | Pfizer Investigational Site | Hawthorne | New York |
| United States | Pfizer Investigational Site | Hollywood | Florida |
| United States | Pfizer Investigational Site | Hoover | Alabama |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Inverness | Florida |
| United States | Pfizer Investigational Site | Iowa City | Iowa |
| United States | Pfizer Investigational Site | Jeffersonville | Indiana |
| United States | Pfizer Investigational Site | Kansas City | Kansas |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kettering | Ohio |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | Lackland AFB | Texas |
| United States | Pfizer Investigational Site | Lake Forest | Illinois |
| United States | Pfizer Investigational Site | Lakeland | Florida |
| United States | Pfizer Investigational Site | Lansdale | Pennsylvania |
| United States | Pfizer Investigational Site | Lathe | Kansas |
| United States | Pfizer Investigational Site | Lehighton | Pennsylvania |
| United States | Pfizer Investigational Site | Loma Linda | California |
| United States | Pfizer Investigational Site | Lorain | Ohio |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Manchester | New Hampshire |
| United States | Pfizer Investigational Site | Manlius | New York |
| United States | Pfizer Investigational Site | Maplewood | Minnesota |
| United States | Pfizer Investigational Site | Marion | Illinois |
| United States | Pfizer Investigational Site | Marrero | Louisiana |
| 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 | Mesa | Arizona |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Modesto | California |
| United States | Pfizer Investigational Site | Montgomery | Alabama |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | New Britain | Connecticut |
| United States | Pfizer Investigational Site | New Brunswick | New Jersey |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Newark | Delaware |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Orlando | Florida |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Papillion | Nebraska |
| United States | Pfizer Investigational Site | Pasadena | California |
| United States | Pfizer Investigational Site | Pawtucket | Rhode Island |
| United States | Pfizer Investigational Site | Pekin | Illinois |
| United States | Pfizer Investigational Site | Peoria | Illinois |
| United States | Pfizer Investigational Site | Peoria | Illinois |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
| United States | Pfizer Investigational Site | Port Charlotte | Florida |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Maine |
| United States | Pfizer Investigational Site | Providence | Rhode Island |
| United States | Pfizer Investigational Site | Rancho Mirage | California |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Rochester | New York |
| 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 | San Francisco | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | Sandusky | Ohio |
| United States | Pfizer Investigational Site | Santa Rosa | California |
| United States | Pfizer Investigational Site | Sarasota | Florida |
| United States | Pfizer Investigational Site | Scottsburg | Indiana |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Sellersville | Pennsylvania |
| United States | Pfizer Investigational Site | Sioux Falls | South Dakota |
| United States | Pfizer Investigational Site | Sioux Falls | South Dakota |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Paul | Minnesota |
| United States | Pfizer Investigational Site | Stanford | California |
| United States | Pfizer Investigational Site | Sterling Heights | Michigan |
| United States | Pfizer Investigational Site | Stuart | Florida |
| United States | Pfizer Investigational Site | Syracuse | New York |
| United States | Pfizer Investigational Site | Syracuse | New York |
| United States | Pfizer Investigational Site | Tamarac | Florida |
| United States | Pfizer Investigational Site | The Villages | Florida |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Valhalla | New York |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | West Bloomfield | Michigan |
| United States | Pfizer Investigational Site | Westminster | Maryland |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, South Africa, Spain, Switzerland, United Kingdom,
Waters DD, LaRosa JC, Barter P, Fruchart JC, Gotto AM Jr, Carter R, Breazna A, Kastelein JJ, Grundy SM. Effects of high-dose atorvastatin on cerebrovascular events in patients with stable coronary disease in the TNT (treating to new targets) study. J Am C — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary outcome is the time to occurrence of a major | |||
| Primary | cardiovascular event, defined as the composite outcome of the | |||
| Primary | following clinical endpoints | |||
| Primary | CHD death | |||
| Primary | Non-fatal/Non-procedure related MI | |||
| Primary | Resuscitated cardiac arrest or fatal/non-fatal stroke | |||
| Secondary | The occurrence of the following clinical events | |||
| Secondary | Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest) | |||
| Secondary | any coronary event (major coronary event or CABG | |||
| Secondary | PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina) | |||
| Secondary | cerebrovascular event (fatal or non fatal stroke, TIA) | |||
| Secondary | peripheral vascular disease; hospitalization with primary diagnosis' of CHF | |||
| Secondary | any cardiovascular event (any of the above); and all-cause mortality. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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