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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00281580 |
Purpose
To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pressure.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Telmisartan Drug: Amlodipine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 4x4 Factorial Design Trial to Evaluate Telmisartan 20, 40 and 80 mg Tablets in Combination With Amlodipine 2.5, 5 and 10 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-Study |
| Enrollment: | 1461 |
| Study Start Date: | April 2006 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| 1235.1.368 Boehringer Ingelheim Investigational Site | |
| Huntsville, Alabama, United States | |
| 1235.1.389 Boehringer Ingelheim Investigational Site | |
| Huntsville, Alabama, United States | |
| 1235.1.411 Boehringer Ingelheim Investigational Site | |
| Huntsville, Alabama, United States | |
| 1235.1.457 Boehringer Ingelheim Investigational Site | |
| Fairhope, Alabama, United States | |
| United States, Arizona | |
| 1235.1.420 Boehringer Ingelheim Investigational Site | |
| Tempe, Arizona, United States | |
| 1235.1.429 Boehringer Ingelheim Investigational Site | |
| Chandler, Arizona, United States | |
| United States, California | |
| 1235.1.357 Boehringer Ingelheim Investigational Site | |
| Long Beach, California, United States | |
| 1235.1.383 Boehringer Ingelheim Investigational Site | |
| Spring Valley, California, United States | |
| 1235.1.465 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1235.1.395 Boehringer Ingelheim Investigational Site | |
| Tustin, California, United States | |
| 1235.1.406 Boehringer Ingelheim Investigational Site | |
| San Diego, California, United States | |
| 1235.1.409 Boehringer Ingelheim Investigational Site | |
| Sacramento, California, United States | |
| 1235.1.414 Boehringer Ingelheim Investigational Site | |
| Santa Ana, California, United States | |
| 1235.1.441 Boehringer Ingelheim Investigational Site | |
| Riverside, California, United States | |
| 1235.1.444 Boehringer Ingelheim Investigational Site | |
| Encinitas, California, United States | |
| 1235.1.445 Boehringer Ingelheim Investigational Site | |
| Encino, California, United States | |
| 1235.1.391 Boehringer Ingelheim Investigational Site | |
| Cudahy, California, United States | |
| United States, Connecticut | |
| 1235.1.453 Boehringer Ingelheim Investigational Site | |
| Milford, Connecticut, United States | |
| United States, Delaware | |
| 1235.1.394 Boehringer Ingelheim Investigational Site | |
| Newark, Delaware, United States | |
| United States, Florida | |
| 1235.1.351 Boehringer Ingelheim Investigational Site | |
| Melbourne, Florida, United States | |
| 1235.1.352 Boehringer Ingelheim Investigational Site | |
| Pembroke Pines, Florida, United States | |
| 1235.1.355 Boehringer Ingelheim Investigational Site | |
| Rockledge, Florida, United States | |
| 1235.1.354 Boehringer Ingelheim Investigational Site | |
| Cooper City, Florida, United States | |
| 1235.1.369 Boehringer Ingelheim Investigational Site | |
| Pembroke Pines, Florida, United States | |
| 1235.1.372 Boehringer Ingelheim Investigational Site | |
| Fort Lauderdale, Florida, United States | |
| 1235.1.390 Boehringer Ingelheim Investigational Site | |
| Hialeah, Florida, United States | |
| 1235.1.449 Boehringer Ingelheim Investigational Site | |
| Pensacola, Florida, United States | |
| 1235.1.397 Boehringer Ingelheim Investigational Site | |
| Pembroke Pines, Florida, United States | |
| 1235.1.398 Boehringer Ingelheim Investigational Site | |
| Melbourne, Florida, United States | |
| 1235.1.405 Boehringer Ingelheim Investigational Site | |
| Mirimar, Florida, United States | |
| 1235.1.407 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| 1235.1.451 Boehringer Ingelheim Investigational Site | |
| Deland, Florida, United States | |
| 1235.1.430 Boehringer Ingelheim Investigational Site | |
| Kissimmee, Florida, United States | |
| 1235.1.396 Boehringer Ingelheim Investigational Site | |
| Fort Lauderdale, Florida, United States | |
| United States, Georgia | |
| 1235.1.380 Boehringer Ingelheim Investigational Site | |
| Tucker, Georgia, United States | |
| United States, Illinois | |
| 1235.1.438 Boehringer Ingelheim Investigational Site | |
| Gurnee, Illinois, United States | |
| United States, Indiana | |
| 1235.1.373 Boehringer Ingelheim Investigational Site | |
| Evansville, Indiana, United States | |
| 1235.1.375 Boehringer Ingelheim Investigational Site | |
| Evansville, Indiana, United States | |
| 1235.1.412 Boehringer Ingelheim Investigational Site | |
| South Bend, Indiana, United States | |
| 1235.1.415 Boehringer Ingelheim Investigational Site | |
| Indianapolis, Indiana, United States | |
| United States, Kansas | |
| 1235.1.356 Boehringer Ingelheim Investigational Site | |
| Wichita, Kansas, United States | |
| 1235.1.379 Boehringer Ingelheim Investigational Site | |
| Lenexa, Kansas, United States | |
| 1235.1.421 Boehringer Ingelheim Investigational Site | |
| Newtown, Kansas, United States | |
| 1235.1.435 Boehringer Ingelheim Investigational Site | |
| Arkansas City, Kansas, United States | |
| United States, Kentucky | |
| 1235.1.423 Boehringer Ingelheim Investigational Site | |
| Louisville, Kentucky, United States | |
| United States, Massachusetts | |
| 1235.1.387 Boehringer Ingelheim Investigational Site | |
| North Dartmouth, Massachusetts, United States | |
| United States, Michigan | |
| 1235.1.424 Boehringer Ingelheim Investigational Site | |
| Bay City, Michigan, United States | |
| United States, Missouri | |
| 1235.1.431 Boehringer Ingelheim Investigational Site | |
| Kansas City, Missouri, United States | |
| 1235.1.385 Boehringer Ingelheim Investigational Site | |
| Florissant, Missouri, United States | |
| 1235.1.452 Boehringer Ingelheim Investigational Site | |
| Florissant, Missouri, United States | |
| 1235.1.365 Boehringer Ingelheim Investigational Site | |
| Kansas City, Missouri, United States | |
| United States, Nevada | |
| 1235.1.454 Boehringer Ingelheim Investigational Site | |
| Henderson, Nevada, United States | |
| United States, New Jersey | |
| 1235.1.426 Boehringer Ingelheim Investigational Site | |
| Cherry Hill, New Jersey, United States | |
| 1235.1.434 Boehringer Ingelheim Investigational Site | |
| Stratford, New Jersey, United States | |
| United States, New York | |
| 1235.1.366 Boehringer Ingelheim Investigational Site | |
| East Syracuse, New York, United States | |
| 1235.1.377 Boehringer Ingelheim Investigational Site | |
| Northport, New York, United States | |
| 1235.1.381 Boehringer Ingelheim Investigational Site | |
| Williamsville, New York, United States | |
| 1235.1.427 Boehringer Ingelheim Investigational Site | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| 1235.1.376 Boehringer Ingelheim Investigational Site | |
| Raleigh, North Carolina, United States | |
| 1235.1.384 Boehringer Ingelheim Investigational Site | |
| Winston-Salem, North Carolina, United States | |
| 1235.1.392 Boehringer Ingelheim Investigational Site | |
| Raleigh, North Carolina, United States | |
| 1235.1.400 Boehringer Ingelheim Investigational Site | |
| Charlotte, North Carolina, United States | |
| 1235.1.403 Boehringer Ingelheim Investigational Site | |
| Lenior, North Carolina, United States | |
| 1235.1.410 Boehringer Ingelheim Investigational Site | |
| Burlington, North Carolina, United States | |
| 1235.1.422 Boehringer Ingelheim Investigational Site | |
| Greenboro, North Carolina, United States | |
| 1235.1.458 Boehringer Ingelheim Investigational Site | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| 1235.1.374 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| 1235.1.413 Boehringer Ingelheim Investigational Site | |
| Marion, Ohio, United States | |
| 1235.1.446 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| United States, Oklahoma | |
| 1235.1.359 Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| 1235.1.361 Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| 1235.1.386 Boehringer Ingelheim Investigational Site | |
| Tulsa, Oklahoma, United States | |
| 1235.1.448 Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| 1235.1.436 Boehringer Ingelheim Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| 1235.1.439 Boehringer Ingelheim Investigational Site | |
| Portland, Oregon, United States | |
| 1235.1.440 Boehringer Ingelheim Investigational Site | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| 1235.1.404 Boehringer Ingelheim Investigational Site | |
| Lansdale, Pennsylvania, United States | |
| 1235.1.408 Boehringer Ingelheim Investigational Site | |
| Erie, Pennsylvania, United States | |
| 1235.1.428 Boehringer Ingelheim Investigational Site | |
| Penndel, Pennsylvania, United States | |
| United States, Rhode Island | |
| 1235.1.370 Boehringer Ingelheim Investigational Site | |
| East Providence, Rhode Island, United States | |
| United States, South Carolina | |
| 1235.1.462 Boehringer Ingelheim Investigational Site | |
| Union, South Carolina, United States | |
| 1235.1.433 Boehringer Ingelheim Investigational Site | |
| Beaufort, South Carolina, United States | |
| United States, Tennessee | |
| 1235.1.363 Boehringer Ingelheim Investigational Site | |
| New Tazewell, Tennessee, United States | |
| 1235.1.382 Boehringer Ingelheim Investigational Site | |
| Selmer, Tennessee, United States | |
| 1235.1.417 Boehringer Ingelheim Investigational Site | |
| Cordova, Tennessee, United States | |
| 1235.1.459 Boehringer Ingelheim Investigational Site | |
| Jackson, Tennessee, United States | |
| United States, Texas | |
| 1235.1.399 Boehringer Ingelheim Investigational Site | |
| Carrollton, Texas, United States | |
| 1235.1.402 Boehringer Ingelheim Investigational Site | |
| Lake Jackson, Texas, United States | |
| 1235.1.460 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| 1235.1.416 Boehringer Ingelheim Investigational Site | |
| Killeen, Texas, United States | |
| 1235.1.432 Boehringer Ingelheim Investigational Site | |
| McKinney, Texas, United States | |
| 1235.1.455 Boehringer Ingelheim Investigational Site | |
| Waco, Texas, United States | |
| 1235.1.456 Boehringer Ingelheim Investigational Site | |
| Odessa, Texas, United States | |
| 1235.1.418 Boehringer Ingelheim Investigational Site | |
| Plano, Texas, United States | |
| 1235.1.442 Boehringer Ingelheim Investigational Site | |
| Austin, Texas, United States | |
| 1235.1.443 Boehringer Ingelheim Investigational Site | |
| Georgetown, Texas, United States | |
| United States, Utah | |
| 1235.1.358 Boehringer Ingelheim Investigational Site | |
| Salt Lake City, Utah, United States | |
| 1235.1.464 Boehringer Ingelheim Investigational Site | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| 1235.1.447 Boehringer Ingelheim Investigational Site | |
| Fredericksburg, Virginia, United States | |
| 1235.1.437 Boehringer Ingelheim Investigational Site | |
| Burke, Virginia, United States | |
| United States, Washington | |
| 1235.1.371 Boehringer Ingelheim Investigational Site | |
| Tacoma, Washington, United States | |
| Argentina | |
| 1235.1.005 Boehringer Ingelheim Investigational Site | |
| Buenos Aires, Argentina | |
| 1235.1.001 Boehringer Ingelheim Investigational Site | |
| BsAs, Argentina | |
| 1235.1.002 Boehringer Ingelheim Investigational Site | |
| Carlos Paz, Argentina | |
| 1235.1.003 Boehringer Ingelheim Investigational Site | |
| Cordoba, Argentina | |
| 1235.1.004 Boehringer Ingelheim Investigational Site | |
| Buenos Aires, Argentina | |
| 1235.1.006 Boehringer Ingelheim Investigational Site | |
| Buenos Aires, Argentina | |
| Brazil | |
| 1235.1.102 Liga de Hipertensão Arterial | |
| Goiania, Brazil | |
| 1235.1.109 Centro de Pesquisas do Hospital do Rim e Hipertensão | |
| São Paulo, Brazil | |
| 1235.1.101 Clínica Médica | |
| Rio de Janeiro, Brazil | |
| 1235.1.103 Unidade de Hipertensão - ICHC - | |
| São Paulo, Brazil | |
| 1235.1.115 Universidade Federal do Pará | |
| Belém, Brazil | |
| Mexico | |
| 1235.1.211 Obesidad Y Prevencion De Enfermedades | |
| Mexico, D.F., Mexico | |
| 1235.1.202 | |
| Guadalajara, Jalisco, Mexico | |
| 1235.1.203 | |
| Col. Magdalena de las Salinas, Mexico | |
| 1235.1.209 Boehringer Ingelheim Investigational Site | |
| Guadalajara, Jalisco, Mexico | |
| 1235.1.207 | |
| Zapopan, Jalisco, Mexico | |
| 1235.1.208 "Ignacio Chávez" | |
| mexico DF, Mexico | |
| 1235.1.205 Fraccionamiento Industrias | |
| San Luis Potosi, Mexico | |
| 1235.1.210 Consultorio Privado | |
| Durango, Durango, Mexico | |
| 1235.1.212 en Factores de riesgo cardiovascular | |
| , mexico, Mexico | |
| 1235.1.204 | |
| Lomas de Guevara, Guadalajara, Mexico | |
| South Africa | |
| 1235.1.301 Boehringer Ingelheim Investigational Site | |
| Pretoria, South Africa | |
| 1235.1.302 Boehringer Ingelheim Investigational Site | |
| Boksburg, South Africa | |
| 1235.1.303 Boehringer Ingelheim Investigational Site | |
| Lenasia, South Africa | |
| 1235.1.304 Boehringer Ingelheim Investigational Site | |
| Durban, South Africa | |
| 1235.1.305 Boehringer Ingelheim Investigational Site | |
| Lenasia, South Africa | |
| 1235.1.306 Boehringer Ingelheim Investigational Site | |
| Cape Town, South Africa | |
| 1235.1.314 Boehringer Ingelheim Investigational Site | |
| Benoni, South Africa | |
| 1235.1.308 Boehringer Ingelheim Investigational Site | |
| Pretoria, South Africa | |
| 1235.1.309 Boehringer Ingelheim Investigational Site | |
| Cape Town, South Africa | |
| 1235.1.310 Boehringer Ingelheim Investigational Site | |
| Cape Town, South Africa | |
| 1235.1.311 Boehringer Ingelheim Investigational Site | |
| Cape Town, South Africa | |
| 1235.1.312 Boehringer Ingelheim Investigational Site | |
| Johannesburg, South Africa | |
| 1235.1.313 Boehringer Ingelheim Investigational Site | |
| Johannesburg, South Africa | |
| 1235.1.307 Boehringer Ingelheim Investigational Site | |
| Krugersdorp, South Africa | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1235.1 |
| Study First Received: | January 24, 2006 |
| Last Updated: | May 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00281580 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |
Amlodipine Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |
