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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00133185 |
The primary objective of this trial is to compare the efficacy and safety of telmisartan 40mg / hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50mg / hydrochlorothiazide 12.5mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: telmisartan 40mg / hydrochlorothiazide 12.5mg Drug: osartan 50mg / hydrochlorothiazide 12.5mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg + HCTZ 12.5 mg in Comparison With Losartan 50mg + HCTZ 12.5 mg in Taiwanese Patients With Mild to Moderate Hypertension |
Estimated Enrollment: | 40 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | January 2005 |
This is a randomised, double-blind, double-dummy, parallel-group study in mild to moderate hypertensive patients treated for eight weeks with either telmisartan 40mg / hydrochlorothiazide 12.5mg or losartan 50mg/ hydrochlorothiazide 12.5mg.
The study will be divided into two phases:
(i) Placebo Run-in Phase (Visit 1 to Visit 2, day -14 (~ day -21) to day 1): Initial screening and withdrawal of current anti-hypertensives is followed by a two week placebo phase with dummy telmisartan 40mg / hydrochlorothiazide 12.5mg and dummy losartan 50mg / hydrochlorothiazide 12.5mg. Baseline assessments are done at the end of the 2 week run-in phase (at Visit 2, day 1).
(ii) Treatment Phase (Visit 2 to 4, day 1 to day 57): This is an eight-weeks double-blind, double-dummy parallel trial with telmisartan 40mg / hydrochlorothiazide 12.5mg or losartan 50mg / hydrochlorothiazide 12.5mg. Final assessments are done at the end of the eight-weeks treatment phase at Visit 4.
Study Hypothesis:
Null and alternative hypothesis The change from baseline in sitting diastolic blood pressure at trough (24 hours post-dosing) at the last visit during the double-blind phase defines the primary endpoint. This trial is to test the non-inferiority of efficacy of telmisartan 40mg / hydrochlorothiazide 12.5mg to losartan 50mg / hydrochlorothiazide 12.5mg. A difference of 3mmHg in reducing sitting diastolic blood pressure would be considered clinically significant.
H0: (Reduction from baseline in sitting diastolic blood pressure at trough of losartan 50mg / hydroclorothiazide 12.5mg group) - (Reduction from baseline in sitting diastolic blood pressure at trough of telmisartan 40mg / hydrochlorothiazide 12.5mg group) > 3 mmHg HA: (Reduction from baseline in sitting diastolic blood pressure at trough of losartan 50mg / hydroclorothiazide 12.5mg group) - (Reduction from baseline in sitting diastolic blood pressure at trough of telmisartan 40mg / hydrochlorothiazide 12.5mg group) ? 3 mmHg
Comparison(s):
Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase.
A 24-hour post-dose timepoint at the last visit of the run-in phase will be specified as the baseline trough measurement.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 502.406 |
Study First Received: | August 22, 2005 |
Last Updated: | January 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00133185 |
Health Authority: | Taiwan, Republic of China: Dept. of Health, Executive Yuan, Taiwan |
Losartan Clotrimazole Benzoates Miconazole Tioconazole |
Vascular Diseases Telmisartan Angiotensin II Hydrochlorothiazide Hypertension |
Anti-Infective Agents 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 Antifungal Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |