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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT05878561
Eligibility Criteria:
* Inclusion Criteria:
* Patients with uncontrolled essential hypertension at screening(V1) under the following criteria:
* Naïve : 140 mmHg ≤ SiSBP \< 180 mmHg
* Use antihypertensive drugs : 130 mmHg ≤ SiSBP \< 180 mmHg
* Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria:
* Selected reference arm : 140 mmHg ≤ SiSBP \< 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP \< 180 mmHg)
* Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2)
* Voluntarily provided a written consent to participate in this clinical study
* Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
* Exclusion Criteria:
* Patients taking three or more antihypertensive drugs of different families
* Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2)
* Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
* Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
* Patients with orthostatic hypotension accompanied by symptoms
* Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05878561
Study Brief:
Protocol Section:
NCT05878561