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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT01042392
Eligibility Criteria:
Inclusion Criteria:
* Outpatients \> 18 years
* Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
* Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
* BP thresholds at visit 1:
* For patients previously treated and uncontrolled: 140≤ office SBP\<180 mmHg
* For patients previously treated, controlled but intolerant: office SBP≥130 mmHg
* BP thresholds at visit 2 (for all patients):
* 160≤office SBP\<180 mmHg AND
* 155≤home SBP\<175 mmHg (3-day period of home blood pressure monitoring just before randomization)
Exclusion Criteria:
* Women of child-bearing potential not using any effective methods of contraception
* Severe hypertension (office BP ≥ 180/110 mmHg)
* Impossibility to stop abruptly previous antihypertensive treatments at visit 1
* Patients previously untreated or patients treated with two or three antihypertensive medications
* History or evidence of a secondary form of hypertension
* History of hypersensitivity to ACEi or renin inhibitors
* History of heart failure, stroke or coronary heart disease
* Serum potassium ≥ 5.2 mmol/l
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01042392
Study Brief:
Protocol Section:
NCT01042392