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:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00134160
Eligibility Criteria:
Inclusion Criteria:
* Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex
* Current antihypertensive treatment with monotherapy
* SBP ≥ 140mmHg or DBP ≥ 90mmHg in a sitting position on two measurements on two clinic visits
* At least one of the following risk factors:
* Diabetes mellitus Type 2;
* History of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (more than 6 months before giving informed consent);
* Diagnosis of asymptomatic cerebrovascular disease;
* History of myocardial infarction (more than 6 months before giving informed consent);
* Diagnosis of angina pectoris or heart failure (New York Heart Association \[NYHA\] functional classification I or II);
* Diagnosis of left ventricular hypertrophy (thickness of the wall of interventricular septum ≥ 12mm on echocardiography or Sv1+Rv5 ≥ 35mm on electrocardiography before informed consent);
* Diagnosis of aortic aneurysm;
* History of aortic dissection (more than 6 months before giving informed consent);
* Diagnosis of arteriosclerotic peripheral arterial obstruction (Fontaine classification from 2 to 4);
* Serum creatinine: 1.2-2.5mg/dL (male); 1.0-2.5mg/dL (female);
* Proteinuria: ≥ +1 (or ≥ 0.3g/g･Cr. estimated from 24-hour urine collection or random urinary protein corrected by urine creatinine).
Exclusion Criteria:
* Secondary hypertension or malignant hypertension
* Heart failure (NYHA functional classification III or IV)
* Required treatment for malignant tumor
* Serious liver or renal dysfunction (serum creatinine \> 2.5mg/dL or with dialysis treatment)
* Not appropriate for change to the test drugs from current therapy for hypertension or coronary diseases (i.e. calcium channel blockers, β-blockers, thiazide diuretics, etc.)
* History of serious adverse drug reactions to angiotensin II receptor blockers or calcium channel blockers
* Patients with other serious reasons (i.e. illness, significant abnormalities, etc.) that investigators judge inappropriate for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
84 Years
Study:
NCT00134160
Study Brief:
Protocol Section:
NCT00134160