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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT00500604
Eligibility Criteria:
Inclusion Criteria:
* Established essential hypertension, untreated or treated but uncontrolled with treatment:
* Office SBP ≥ 160 mmHg for untreated patients
* Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive drug.
* Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
* ACE inhibitor / calcium channel blocker
* Beta blocker / calcium channel blocker
* Beta blocker / low dose diuretic
* ACE inhibitor / low dose diuretic
Exclusion Criteria:
* SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1
* Known or suspected causes of secondary hypertension
* Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
* Type 1 diabetes mellitus
* Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject
* Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
* Known contraindications to any of the study drugs
* Concomitant use of any other antihypertensive treatment
* Use of any of the investigational products for this study within the 3 months prior to the study
* Inability to obtain a valid HBPM recording i.e., obesity, arm circumference \> 32 cm or arrhythmia
* Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
* Pregnant or breast-feeding women
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00500604
Study Brief:
Protocol Section:
NCT00500604