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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01819220
Eligibility Criteria:
Inclusion Criteria:
* consent to the study
* Male or Female ≥ 20 years
* Patients taking less than 1 antihypertensive medications or not taking antihypertensive medications. Hypertension defined at the screening visit as follows): 140mmHg \< MSSBP or MSDBP \> 90mmHg at screening
* Hypertensive patients with non diabetic metabolic syndrome will be enrolled. Metabolic syndrome is defined according to NCEP guideline. (3 or more than) ① Abdominal obesity: Waist circumference M ≥ 90cm, F ≥ 80cm
② Hypertriglyceridaemia: Triglycerides ≥ 150mg/dL
③ Low HDL cholesterol Men: HDL cholesterol ≤ 40mg/dL Women: HDL cholesterol ≤ 50mg/dL
④ Elevated blood pressure (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 85 mmHg, or current use of antihypertensive drugs)
⑤ Impaired fasting glucose: fasting plasma glucose ≥ 100 mg/dL
* Patient not taking statin medication and if the patient had ate statin medication the last duration must be before 3 months.
Exclusion Criteria:
* • Women of child-bearing potential without a contraceptive measure
* (Pregnant or nursing women
* Known or suspected contraindications: history of allergy or hypersensitivity
* History of clinically significant allergies including asthma and/or multiple drug allergies
* Patients taking more than 2 antihypertensive medications
* Patient taking statin medication and taking statin within 3 months
* MSSBP \> 180 mmHg or MSDBP \> 110 mmHg at any time during the study
* Evidence of a secondary form of hypertension)
* History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) for 12 months prior to Visit 1
* History of heart failure Grade II - IV according to the NYHA classification
* Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
* Concomitant unstable angina pectoris
* Clinically significant valvular heart disease
* Patients with Type 1 or Type 2 diabetes mellitus
* Evidence of hepatic disease as determined by one of the following: AST or ALT values ≥ 3 x UNL, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt
* Evidence of renal impairment as determined by one of the following: serum creatinine \>2mg/dL , history of dialysis, or history of nephrotic syndrome
* Protein in U/A values 2+ ≤
* Serum potassium values \< 3.2 or \> 5.2 mmol/L
* History of malignancy of any organ system within the past 5 years, treated or untreated, including leukemia and lymphoma, as further defined in the full protocol
* Chronic use of NSAIDs
* Use of cyclooxygenase-2 inhibitors (COX-2 inhibitors
* Use of niacin \> 100 mg/d
* Use of loop diuretics
* Use of statin shorter than 3 months
* Inability to discontinue prior antihypertensive drugs as specified in the full protocol
* persons directly involved in the execution of this protocol
* Volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values
* Any severe, life-threatening disease within the past five years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01819220
Study Brief:
Protocol Section:
NCT01819220