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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00257491 |
To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80 mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential hypertension.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Telmisartan Drug: Telmisartan/HCTZ |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study to Evaluate the Trough and Peak Effect of Once Daily Micardis Plus (Telmisartan 80mg / Hydrochlorothiazide 12.5 mg) by 24 ABPM in Patients With Mild to Moderate Essential Hypertension |
Estimated Enrollment: | 20 |
Estimated Study Completion Date: | August 2006 |
This study is designed as an open label study. After a 2-week placebo run-in phase, qualified patients will be administered with telmisartan 80mg for 2 weeks, then forcefully titrated to telmisartan 80 mg and hydrochlorothiazide 12.5 mg fixed dose combination for 6 weeks. 24 hour ABPM will be performed at the end of placebo run-in period (baseline) and after 8 weeks of active treatment.
Study Hypothesis:
The primary analyses will be the calculation of trough to peak ratios (T/P ratios) for DBP and SBP. The T/P ratio will be calculated on the basis of changes in hourly means (related to dosing time) from baseline (DeltaHM). Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. Thus, T/P is calculated as T/P = mean(DeltaHM22 - DeltaHM24)/min (DeltaHM2 - DeltaHM8).
Comparison(s):
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
History of mild-to-moderate essential hypertension defined by a mean seated DBP >= 95 and <= 109 mmHg, and SBP < 180mmHg measured by manual cuff sphygmomanometer at visit 2.
Note: The manual cuff value is calculated as the mean of three seated measurements collected 2 minutes apart, after the patient has been seated quietly for 5 minutes. For calculation of mean values by the investigator, decimal places should be rounded to integers as usual (e.g., a DBP of 94.7 would be rounded to 95 mmHg and a DBP of 109.3 would be rounded to 109 mmHg).
5.Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion).
Exclusion Criteria:
Pre-menopausal women (last menstruation <= 1 year prior to start of screening):
Any woman:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
China | |
Shanghai Ruijin Hospital | |
Shanghai, China, 200025 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai |
Study ID Numbers: | 502.488 |
Study First Received: | November 22, 2005 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00257491 |
Health Authority: | China: State Food and Drug Administration |
Vascular Diseases Essential hypertension Telmisartan |
Angiotensin II Hydrochlorothiazide Hypertension |
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Membrane Transport Modulators Angiotensin II Type 1 Receptor Blockers Natriuretic Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |