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Sponsors and Collaborators: |
Boehringer Ingelheim Pharmaceuticals GlaxoSmithKline Bayer |
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00034840 |
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 |
MedlinePlus related topics: | High Blood Pressure |
Drug Information available for: | Valsartan Telmisartan |
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. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Show 35 Study Locations |
Boehringer Ingelheim Pharmaceuticals |
GlaxoSmithKline |
Bayer |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
Related Info 
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Study ID Numbers: | 502.327 |
First Received: | May 2, 2002 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00034840 |
Health Authority: | United States: Food and Drug Administration |
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