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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT00940667
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years of age
* Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP ≥ 90 mmHg for drug-treated patient, sit DBP ≥ 95 mmHg for drug-naïve patient)
* Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)
Exclusion Criteria:
* mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
* mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg treatment
* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
* Secondary hypertensive patient or suspected to be
* Uncontrolled diabetes mellitus patients
* Severe heart disease or severe neurovascular disease
* Known as severe or malignant retinopathy
* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
* History of malignancy tumor
* History of autoimmune disease
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, has an intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with othe reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00940667
Study Brief:
Protocol Section:
NCT00940667