Status:
COMPLETED
Benidipine-based Comparison of Angiotensin Receptors, β-blockers, or Thiazide Diuretics in Hypertensive Patients
Lead Sponsor:
Seiji Umemoto, M.D., Ph.D.
Collaborating Sponsors:
The Japanese Society of Hypertension
Yamaguchi University Hospital
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- Outpatients who are required a combination therapy with sitting systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.
- Outpatients aged over 40 years and less than 85 years (inclusive), regardless of sex.
- Previously untreated patients or patients who are on other therapy, which can be converted to 4mg of benidipine.
- Patients who can be treated with benidipine, angiotensin receptor blockers, β-blockers, and thiazide diuretics.
Exclusion
- Seated systolic blood pressure ≥ 200 mmHg or seated diastolic blood pressure ≥ 120 mmHg.
- Secondary hypertension.
- Type I diabetes mellitus or type 2 diabetes on insulin treatment.
- History of cerebrovascular disorder, myocardial infarction, angina pectoris, coronary angioplasty or coronary artery bypass graft surgery within 6 months prior to enrolment in the study.
- Heart failure (New York Heart Association \[NYHA\] functional classification II, III or IV).
- Chronic atrial fibrillation or atrial flutter.
- Congenital heart disease or a history of rheumatic heart disease.
- Severe peripheral arterial disease (Fontaine Class II, III or IV).
- Serious liver dysfunction (AST or ALT ≥100 IU / l).
- Serious renal dysfunction (serum creatinine ≥ 2mg/dl).
- History of malignancy 5 years prior to study entry.
- Pregnancy.
- Compliance rate \< 70% assessed by a patient interview.
- Known hypersensitivity or contraindication to benidipine, angiotensin receptor blockers, β-blockers, and thiazide diuretics.
- Other serious illness or significant abnormalities that the investigator judges inappropriate for the study
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
3501 Patients enrolled
Trial Details
Trial ID
NCT00135551
Start Date
May 1 2003
End Date
November 1 2010
Last Update
February 22 2012
Active Locations (1)
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1
Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, Japan, 755-8505