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 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
NCT ID:
NCT02031861
Eligibility Criteria:
Inclusion Criteria:
* Voluntarily participate and must sign informed consent form
* Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
* Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 mmHg
Exclusion Criteria:
* Secondary hypertension and malignant hypertension
* Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
* Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
* Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
* Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
* Kock pouch
* Sever gastrointestinal stenosis
* Abnormal laboratory values with clinical significance, including serum potassium \<3.5 or \>5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) \>2-fold upper limit of normal (ULN), Cr \>ULN
* Uric acid \>ULN with the diagnosis of gout
* Gastrointestinal abnormalities or surgery that may interfere with drug absorption
* Hyperthyroidism or hypothyroidism
* Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
* Heavy smokers (\>25 cigarettes every day), alcoholics (\>250 ml liquor every day), drug addicts
* Psychological diseases, acrasia, cannot express explicitly
* Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
* Anxiety disorders, depression or cannot follow study protocol
* BMI \>30
* Night shift, irregular sleep patterns or insomnia
* participate in other clinical trials within 3 months
* other conditions that investigators consider unsuitable for participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02031861
Study Brief:
Protocol Section:
NCT02031861