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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT01876368
Eligibility Criteria:
Inclusion Criteria:
* patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
* treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and \< 180 mmHg after washout epoch and after 4 weeks run-in epoch
* untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and \< 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and \< 180 mmHg after 4 weeks run-in epoch
* patients must successfully complete ABPM and pass technical requirements to be qualified for randomization
Exclusion Criteria:
* Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
* History of angioedema, drug-related or otherwise
* History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease (PKD), drug-induced hypertension
* Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01876368
Study Brief:
Protocol Section:
NCT01876368