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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00168857 |
Purpose
A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Diabetic Nephropathies |
Drug: telmisartan Drug: losartan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment |
| Official Title: | Telmisartan vs. Losartan for Improvement of Renal Function in Hypertensive Diabetic Patients With Overt Nephropathy. |
| Estimated Enrollment: | 856 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | February 2007 |
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Boehringer Ingelheim Investigational Site | |
| Montgomery, Alabama, United States | |
| United States, Arkansas | |
| Boehringer Ingelheim Investigational Site | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Torrance Clinical Research | |
| Torrance, California, United States | |
| UCI Medical Center | |
| Orange, California, United States | |
| VA of Greater Los Angeles | |
| Los Angeles, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| Santa Ana, California, United States | |
| VA San Diego Healthcare System | |
| San Diego, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| UCLA Medical Center | |
| Sylmar, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| Lancaster, California, United States | |
| United States, Colorado | |
| Boehringer Ingelheim Investigational Site | |
| Wheatridge, Colorado, United States | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Boehringer Ingelheim Investigational Site | |
| Hollywood, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Pembroke Pines, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Ocala, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Largo, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States | |
| Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Rush Presbyterian - St. Lukes Medical Center | |
| Chicago, Illinois, United States | |
| United States, Iowa | |
| Boehringer Ingelheim Investigational Site | |
| Demoine, Iowa, United States | |
| United States, Louisiana | |
| Boehringer Ingelheim Investigational Site | |
| Shreveport, Louisiana, United States | |
| Louisiana State University Health Science Center | |
| New Orleans, Louisiana, United States | |
| United States, Maryland | |
| Boehringer Ingelheim Investigational Site | |
| Towson, Maryland, United States | |
| United States, Massachusetts | |
| Boehringer Ingelheim Investigational Site | |
| Springfield, Massachusetts, United States | |
| Boehringer Ingelheim Investigational Site | |
| Boston, Massachusetts, United States | |
| United States, New Jersey | |
| Boehringer Ingelheim Investigational Site | |
| Eatontown, New Jersey, United States | |
| University of Medicine and Dentistry of New Jersey | |
| Newark, New Jersey, United States | |
| United States, New York | |
| Boehringer Ingelheim Investigational Site | |
| Flushing, New York, United States | |
| Northport VAMC - Medical Service (111) | |
| Northport, New York, United States | |
| Winthrop University Hospital | |
| Mineola, New York, United States | |
| Harlem Hospital | |
| New York, New York, United States | |
| United States, North Carolina | |
| Wake Nephrology Associates, PA | |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| The Cleveland Foundation | |
| Cleveland, Ohio, United States | |
| United States, Pennsylvania | |
| VA Pittsburgh Healthcare System | |
| Pittsburgh, Pennsylvania, United States | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States | |
| United States, Texas | |
| Boehringer Ingelheim Investigational Site | |
| San Antonio, Texas, United States | |
| The University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States | |
| University of Texas Health and Science Center at San Antonio | |
| San Antonio, Texas, United States | |
| United States, Vermont | |
| University of Vermont | |
| Burlington, Vermont, United States | |
| United States, Virginia | |
| University of Virginia Health Science Center | |
| Charlottesville, Virginia, United States | |
| United States, Washington | |
| Boehringer Ingelheim Investigational Site | |
| Gig Harbor, Washington, United States | |
| Boehringer Ingelheim Investigational Site | |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| Clement J. Zablocki Veterans Administration Medical Center | |
| Milwaukee, Wisconsin, United States | |
| Argentina | |
| Boehringer Ingelheim Investigational Site | |
| Buenos aIRES, Argentina | |
| Boehringer Ingelheim Investigational Site | |
| Córdoba, Argentina | |
| Boehringer Ingelheim Investigational Site | |
| Paraná, Argentina | |
| Boehringer Ingelheim Investigational Site | |
| SANTA FE, Argentina | |
| Hospital San Bernardo | |
| Salta, Argentina | |
| Boehringer Ingelheim Investigational Site | |
| Rosario, Santa Fé, Argentina | |
| Clinica Coronel Suarez | |
| CORONEL SUAREZ, Argentina | |
| Boehringer Ingelheim Investigational Site | |
| Provincia de Buenos Aires, Argentina | |
| Australia, Queensland | |
| Boehringer Ingelheim Investigational Site | |
| Kippa-Ring, Queensland, Australia | |
| Australia, South Australia | |
| Lyell McEwin Hospital Department of medicine | |
| Elizabeth, South Australia, Australia | |
| Australia, Victoria | |
| Boehringer Ingelheim Investigational Site | |
| Melbourne, Victoria, Australia | |
| Geelong Clinical Research Centre | |
| Geelong, Victoria, Australia | |
| Brazil | |
| Boehringer Ingelheim Investigational Site | |
| Vila Clementino, São Paulo, Brazil | |
| Universidade Federal do Pará | |
| Belém, Brazil | |
| Boehringer Ingelheim Investigational Site | |
| Botucatu, Brazil | |
| Faculdade de Medicina Universidade Federal de Juiz de Fora | |
| Juiz de Fora ¿ MG, Brazil | |
| Canada, Alberta | |
| Boehringer Ingelheim Investigational Site | |
| Red Deer, Alberta, Canada | |
| Boehringer Ingelheim Investigational Site | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| BC Endocrine Research Foundation | |
| Vancouver, British Columbia, Canada | |
| Endocrine Research Society | |
| Vancouver, British Columbia, Canada | |
| Canada, Manitoba | |
| University of Manitoba, Diabetes Research Group | |
| Winnipeg, Manitoba, Canada | |
| Canada, Nova Scotia | |
| Division of Respirology | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| Boehringer Ingelheim Investigational Site | |
| Timmins, Ontario, Canada | |
| Credit Valley Hospital | |
| Mississauga, Ontario, Canada | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada | |
| Boehringer Ingelheim Investigational Site | |
| Kitchener, Ontario, Canada | |
| Humber River Regional Hospital, Dialysis Unit | |
| Weston, Ontario, Canada | |
| Boehringer Ingelheim Investigational Site | |
| London, Ontario, Canada | |
| Sunnybrook & Woman's College Health Science Centre | |
| Toronto, Ontario, Canada | |
| The Ottawa Hospital - Riverside Campus | |
| Ottawa, Ontario, Canada | |
| Boehringer Ingelheim Investigational Site | |
| Oakville, Ontario, Canada | |
| LIfestyle Metabolism Centre - Thornhill | |
| Thornhill, Ontario, Canada | |
| Canada, Quebec | |
| Boehringer Ingelheim Investigational Site | |
| Laval, Quebec, Canada | |
| CHUM - Hote-Dieu | |
| Montreal, Quebec, Canada | |
| Hopital Maisonneuve Rosemont | |
| Montreal, Quebec, Canada | |
| CHUS - Hopital Fleurimont | |
| Sherbrooke, Quebec, Canada | |
| Canada, Saskatchewan | |
| Boehringer Ingelheim Investigational Site | |
| Saskatoon, Saskatchewan, Canada | |
| Korea, Republic of | |
| Yongdong Severance Hospital | |
| Seoul, Korea, Republic of | |
| National Health Insurance Corporation, Ilsan Hospital | |
| Gyunggido, Korea, Republic of | |
| Dongsan Medical Center | |
| Daegu, Korea, Republic of | |
| Mexico | |
| Boehringer Ingelheim Investigational Site | |
| Guadalajara, Jalisco, Mexico | |
| Cardiologia | |
| México, D.F., Mexico | |
| Fracc. Magallanes | |
| Acapulco Guerrero, Mexico | |
| Cardiology | |
| Guadalajara, Mexico | |
| Dep of Neurology | |
| Metepec, Mexico | |
| Boehringer Ingelheim Investigational Site | |
| Col. Sección XVI, Deleg. Tlalpan, Mexico | |
| Hospital Civil Nuevo de Guadalajara | |
| GUADALAJARA, Mexico | |
| New Zealand | |
| Boehringer Ingelheim Investigational Site | |
| Auckland, New Zealand | |
| 1st Floor Hagely Hostel | |
| Christchurch, New Zealand | |
| Taiwan | |
| Cathay General Hospital | |
| Taipei, Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan | |
| Buddhist Tzu Chi General Hospital | |
| Chiayi, Taiwan | |
| Chi Mei Medical Center | |
| Tainan, Taiwan | |
| Tri-Service General Hospital | |
| Taipei, Taiwan | |
| Buddhist Tzu Chi General Hospital | |
| Hualien, Taiwan | |
| Thailand | |
| Thummasart University Hospital | |
| Bangkok, Thailand | |
| Srinagarind Hospital | |
| Khon Kaen, Thailand | |
| Bumrungrad Hospital | |
| Bangkok, Thailand | |
| Pramongkutklao Hospital | |
| Bangkok, Thailand | |
| Siriraj Hospital, Division of Hypertension | |
| Bangkok, Thailand | |
| Maharaj Nakom Chiang Mai Hospital | |
| Chiang Mai, Thailand | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| Study ID Numbers: | 502.397 |
| Study First Received: | September 9, 2005 |
| Last Updated: | March 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00168857 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Losartan Diabetic Nephropathies Molecular Mechanisms of Pharmacological Action Diabetes Mellitus Vascular Diseases Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |
Angiotensin II Type 1 Receptor Blockers Urologic Diseases Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Kidney Diseases Telmisartan Anti-Arrhythmia Agents Diabetes Complications Hypertension |
