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Sponsors and Collaborators: |
COPE Trial Group The Japanese Society of Hypertension Yamaguchi University Hospital Kyowa Hakko Kogyo Co., Ltd. |
Information provided by: | COPE Trial Group |
ClinicalTrials.gov Identifier: | NCT00135551 |
A number of major clinical trials have demonstrated the clinical benefits of lowering blood pressure and have indicated that a majority of patients with hypertension will require more than one drug to achieve optimal blood pressure control.
There is little data showing which antihypertensive combination best protects patients from cardiovascular events and which best achieves the target blood pressure with the fewest adverse events.
The COPE trial is planned to investigate, in patients with hypertension, which combination of the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse drug effects.
Condition | Intervention | Phase |
Cardiovascular Disease |
Drug: Benidipine hydrochloride Drug: Angiotensin receptor blockers Drug: β-blockers Drug: Thiazide diuretics |
Phase IV |
MedlinePlus related topics: | High Blood Pressure |
ChemIDplus related topics: | Benidipine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Combination Therapy of Hypertension to Prevent Cardiovascular Events (COPE) Trial |
Estimated Enrollment: | 3000 |
Study Start Date: | May 2003 |
Ages Eligible for Study: | 40 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Yamaguchi | |||||
Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine | |||||
Ube, Yamaguchi, Japan, 755-8505 |
COPE Trial Group |
The Japanese Society of Hypertension |
Yamaguchi University Hospital |
Kyowa Hakko Kogyo Co., Ltd. |
Principal Investigator: | Toshio Ogihara, MD, PhD | Department of Geriatric Medicine, Osaka University Graduate School of Medicine |
Study Chair: | Takao Saruta, MD, PhD | Department of Internal Medicine, Keio University School of Medicine |
Study ID Numbers: | copeadministrator |
First Received: | August 24, 2005 |
Last Updated: | March 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00135551 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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