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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Collaborators: |
GlaxoSmithKline Bayer |
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00034840 |
Purpose
The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: telmisartan, valsartan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | A Prospective, Randomized, Double-blind, Forced Titration Trial to Compare the Efficacy of Micardis® (Telmisartan) (80 mg p.o. Once Daily) and Valsartan (160 mg p.o. Once Daily) in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Mild-to-moderate hypertension defined as a baseline mean seated DBP of greater than or equal to 95 mm Hg and less than or equal to 109 mm Hg and a baseline 24-hour ABPM mean DBP of greater than or equal to 85 mm Hg.
Exclusion Criteria:
Pre-menopausal women (last menstruation = 1 year prior to signing informed consent) who:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Contacts and Locations
Hide Study Locations| United States, California | |
| Memorial Research Medical Clinic | |
| Long Beach, California, United States, 90806 | |
| National Research Institute | |
| Los Angeles, California, United States, 90057 | |
| Orange County Research Center | |
| Orange, California, United States, 92868 | |
| United States, Connecticut | |
| University of Conn. Health Services Center, Hypertension and Vascular Disease | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| Alan Graff | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Orlando Clinical Research Center | |
| Orlando, Florida, United States, 32806 | |
| Greater Ft. Lauderdale Heart Group Research | |
| Ft. Lauderdale, Florida, United States, 33308 | |
| United States, Georgia | |
| So. Clinical Research and Management, Inc. | |
| Augusta, Georgia, United States, 30904 | |
| United States, Illinois | |
| Rush Presbyterian/St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| University of Maryland/Nephrology Clinical Research Unit | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Oklahoma | |
| Oklahoma Cardiovascular and Hypertension Center | |
| Oklahoma City, Oklahoma, United States, 73132 | |
| United States, Oregon | |
| Michael A. Azorr, M.D. | |
| Portland, Oregon, United States, 97232 | |
| United States, Pennsylvania | |
| Harleysville Medical Associates | |
| Harleysville, Pennsylvania, United States, 19438 | |
| United States, Texas | |
| Trinity Hypertension Research Institute/Punzi Medical Center | |
| Carrollton, Texas, United States, 75006 | |
| United States, Wisconsin | |
| UW Health/Physicians Plus Center for Clinical Trials | |
| Madison, Wisconsin, United States, 53715 | |
| Canada, Alberta | |
| Heart Health Institute | |
| Calgary, Alberta, Canada, T2E 7C5 | |
| Canada, Newfoundland and Labrador | |
| Dr. Dennis O'Keefe | |
| Mount Pearl, Newfoundland and Labrador, Canada, A1N 2C3 | |
| Canada, Nova Scotia | |
| Dr. William Booth | |
| Antigonish, Nova Scotia, Canada, B2G 2C2 | |
| MSHJ Research Assoc. | |
| Halifax, Nova Scotia, Canada, B3K 5R3 | |
| Canada, Ontario | |
| Dr. Joseph Berlingieri | |
| Burlington, Ontario, Canada, L7R 2H3 | |
| BBM Clinical Research Ltd. | |
| Courtice, Ontario, Canada, L1E 3C3 | |
| Centre for Activity and Aging | |
| London, Ontario, Canada, N6G 2M3 | |
| Sunnybrook & Women's College Health Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Dr. Richard Tytus | |
| Hamilton, Ontario, Canada, L8M 1K7 | |
| Dr. William Mahoney | |
| Corunna, Ontario, Canada, N0N 1G0 | |
| Total Concept Health Care | |
| Kitchener, Ontario, Canada, N2C 2N9 | |
| Dr. Martyn Chilvers | |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Canada, Quebec | |
| Theradev Clinical Research, Inc. | |
| Granby, Quebec, Canada, J2G 8Z9 | |
| Centre de Cardiologie | |
| Saint Lambert, Quebec, Canada, J4P 2H4 | |
| Centre Hospital Quebec - PAC CHUL Unite de Recherche | |
| Sainte-Foy, Quebec, Canada, G1V 4G2 | |
| Invascor, Longueuil | |
| Longueuil, Quebec, Canada, J4N 1E1 | |
| Q&T Research | |
| Sherbrooke, Quebec, Canada, J1H 4J6 | |
| Hotel Dieu de St-Jerome | |
| Saint Jerome, Quebec, Canada, J7Z 5T3 | |
| Canada, Saskatchewan | |
| Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| Study ID Numbers: | 502.327 |
| Study First Received: | May 2, 2002 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00034840 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
hypertension telmisartan valsartan boehringer |
|
Molecular Mechanisms of Pharmacological Action Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |
Angiotensin II Type 1 Receptor Blockers Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Valsartan Hypertension |