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Sponsored by: |
The Japanese Society of Hypertension |
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Information provided by: | The Japanese Society of Hypertension |
ClinicalTrials.gov Identifier: | NCT00125463 |
The purpose of this study is to compare an angiotensin II receptor antagonist (candesartan cilexetil– Blopress®) and a calcium channel blocker (amlodipine besilate– Norvasc®/Amlodin®) in terms of the incidence of cardiovascular events among high-risk hypertensive patients.
Condition | Intervention | Phase |
---|---|---|
Hypertension Cardiovascular Diseases |
Drug: Candesartan cilexetil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients |
Estimated Enrollment: | 3200 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | December 2005 |
Hypertension continues to be a major public health issue in the world. To combat this problem, many antihypertensive drugs have been developed and proven effective at controlling blood pressure in the last half century. In recent decades, antihypertensive drugs have been shown to have cardiovascular benefits beyond the reduction of blood pressure, and the focus has shifted to clarification of these effects. Angiotensin II receptor antagonists and calcium channel blockers are the most widely used antihypertensive drugs in Japan. However, these two classes of drugs have not yet been compared with respect to their efficacy for treating cardiovascular events.
Comparison: Response-dependent dose titration and blinded assessment of endpoints in high risk hypertensive patients treated with either an angiotensin II receptor antagonist (candesartan cilexetil) compared to a third-generation calcium channel blocker (amlodipine besilate).
Ages Eligible for Study: | 25 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following risk factors:
Exclusion Criteria:
Japan, Yoshidakonoe-cho, Sakyo-ku, Kyoto | |
Kyoto University | |
Kyoto, Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan, 606-8501 |
Principal Investigator: | Takao Saruta, M.D. | Keio University |
Study ID Numbers: | JSH-00001 |
Study First Received: | July 29, 2005 |
Last Updated: | August 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00125463 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Hypertension clinical trial Candesartan Antihypertensive Survival Evaluation in Japan trial candesartan cilexetil amlodipine besilate |
Candesartan cilexetil Candesartan Vascular Diseases |
Angiotensin II Amlodipine Hypertension |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |