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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT02206659
Eligibility Criteria:
Inclusion Criteria:
* Chinese male or female aged 18 to 75 years
* Mild to moderate hypertension defined as a morning DBP \_95 and \<110 mm Hg at visit1 and visit 2. Mean sitting systolic pressure (SBP) must be \<180 mm Hg
* Ability to provide written informed consent
Exclusion Criteria:
* Women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone)
* Known or suspected secondary hypertension
* Known history of any chronic hepatic disease
* Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
* New York Heart Association (NYHA) functional class congestive heart failure (CHF) III-IV
* Unstable angina pectoris
* Myocardial infarction or percutaneous transluminal coronary angiography (PTCA) or cardiac surgery within the preceding three months
* Clinical relevant cardiac arrhythmias as determined by the clinical investigator
* Hypertrophic obstructive cardiomyopathy or clinically significant valvular disease
* Evidence of retinal hemorrhages/exudates
* Clinical significant hyperkalemia as defined by serum potassium level \>6.0 milliequivalents (mEq)/L
* Insulin-dependent diabetes mellitus
* Non-insulin-dependent diabetes mellitus with poor glucose control as defined by persistent fasting blood sugar \>200 mg/dl, peripheral neuropathy or autonomic neuropathy
* Known drug or alcohol dependency
* Administration of any diuretic, ACE inhibitor or angiotensin II receptor antagonist within two weeks before run-in period
* Administration of medication known to affect blood pressure during trial period
* Patients receiving any investigational therapy within one month of signing the informed consent form
* Known hypersensitivity to any component of the formulation
* Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02206659
Study Brief:
Protocol Section:
NCT02206659