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Sponsors and Collaborators: |
Sanofi-Aventis Bristol-Myers Squibb |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00264212 |
To compare the antihypertensive efficacy and tolerability of irbesartan and irbesartan-hydrochlorothiazide fixed combination therapy with amlodipine and amlodipine plus hydrochlorothiazide in the treatment of isolated systolic hypertension.
Condition | Intervention | Phase |
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Hypertension |
Drug: irbesartan and irbesartan-hydrochlorothiazide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre Prospective Randomized Open-Label 12-Week Study With Blinded Evaluation Comparing the Efficacy and Safety of Irbesartan and Irbesartan-Hydrochlorothiazide Fixed Combination With Amlodipine and Amlodipine Plus Hydrochlorothiazide in Elderly Patients With Isolated Systolic Hypertension |
Estimated Enrollment: | 436 |
Study Start Date: | August 2004 |
Ages Eligible for Study: | 60 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main criteria are listed hereafter:
Inclusion Criteria:
at Screening
Hypertension defined as:
AND seated Diastolic Blood Pressure (DBP)< 90 mmHg
at Randomization
Exclusion Criteria (at Screening):
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Chile | |
Sanofi-aventis | |
SANTIAGO, Chile | |
China | |
Sanofi-aventis | |
SHANGAI, China | |
Indonesia | |
Sanofi-aventis | |
JAKARTA, Indonesia | |
Korea, Republic of | |
Sanofi-aventis | |
SEOUL, Korea, Republic of | |
Mexico | |
Sanofi-aventis | |
MEXICO, Mexico | |
Philippines | |
Sanofi-aventis | |
MANILA, Philippines | |
Taiwan | |
Sanofi-aventis | |
TAIPEI, Taiwan | |
Thailand | |
Sanofi-aventis | |
BANGKOK, Thailand |
Study Director: | Pascale BLONDIN, MD | Sanofi-Aventis |
Study ID Numbers: | R_8791 |
Study First Received: | December 9, 2005 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00264212 History of Changes |
Health Authority: | Indonesia : National Agency of Drug and Food Control (NA-DFC) |
Angiotensin II Type 1 Receptor Blockers Sodium Chloride Symporter Inhibitors Diuretics Irbesartan Vascular Diseases Cardiovascular Agents |
Angiotensin II Antihypertensive Agents Hydrochlorothiazide Amlodipine Hypertension |
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Irbesartan Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Hypertension |