Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT00135551
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT00135551
Study Brief:
Protocol Section:
NCT00135551