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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT01625494
Eligibility Criteria:
Inclusion criteria :
* Men and women ≥18 years old
* Established essential hypertension
* Treated with irbesartan 150 mg or amlodipine 5 mg as monotherapy for at least 2 weeks
* With uncontrolled systolic BP (blood pressure) defined as ≥140 mm Hg assessed by OBPM (office blood pressure measurements)
* Signed written informed consent obtained prior to inclusion to the study
Exclusion criteria:
* Mean systolic BP ≥180 mm Hg and/or mean diastolic BP ≥110 mm Hg by OBPM on Visit 1
* Known or suspected causes of secondary hypertension
* Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only has one functioning kidney
* Known contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination
* History of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
* Severe hepatic impairment (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>5 times the upper normal limit (ULN) or history of hepatic encephalopathy, esophageal varices or portocaval shunt)
* Severe renal impairment (glomerular filtration rate \<30 ml/min)
* Concomitant use of any other antihypertensive treatment except of Irbesartan and Amlodipine
* Administration of any other investigational drug within 30 days before inclusion
* Presence of any other conditions that would restrict or limit the patient participation for the duration of the study
* Pregnant or breast feeding women
* Women of childbearing potential unable or unwilling to use an acceptable method to avoid pregnancy for the entire study period
* Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
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
Study:
NCT01625494
Study Brief:
Protocol Section:
NCT01625494