Effect of Nebivolol compared to Atenolol on central aortic pressure and arterial stiffness in patient with hypertensio

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0003151
• Lead Sponsor: Chungnam National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1.Patients who got the explanation on the purpose, content and characteristics of the investigational drug and have voluntarily agreed.
2.Male and female adults age 20 ~ 75.
3.Patients with hypertension, defined by systolic blood pressure exceeding 140 mmHg or diastolic blood pressure exceeding 90 mmHg when measured at the hospital on Baseline (Visit 1).

Exclusion Criteria

1. Severe hypertension patients who showed systolic blood pressure over 180mmHg or diastolic blood pressure over 110mmHg or orthostatic hypotensive patients with hypertension symptoms on Baseline visit(Visit 1).
2. Patients who are diagnosed or suspected to have secondary hypertension (renovascular diseases, adrenal medulla, hypoadrenocorticism, aortic coarctation, aldosterone hyperlipidemia, Cushing's syndrome, chrome affinity cell tumors, polycystic kidney diseases, etc.)
3. Patients who were administered antihypertensive drugs within 4 weeks prior to Baseline visit (Visit 1).
4. Patients who have severe peripheral vascular diseases with ankle-brachial index below 0.9.
5. Patients with clinically significant bradycardia, ventricular tachycardia, atrial fibrillation, atrial flutter or other arrhythmia that was decided to be clinically significant by investigators.
6. Severe asthma and COPD patients or patients with symptoms of asthma and COPD.
7. Pregnant, lactating women and childbearing aged women who do not use any contraception proven by the clinical trial (including the condition of medically impossible to be pregnant) or whose pregnant reaction test result was positive.
- Medically impossible for childbearing: Menopause (i.e. Amenorrhea for over 12 months continuously), hysterectomy, bilateral oophorectomy and one or more tubal ligations identified during interview or any available medical record.
- Medically acceptable contraception: Intrauterine device (loop, mirena), physical blockers (condoms), chemical blockers (spermicide, etc.), contraception to avoid transplant (implanon, etc.), salpingectomy, ligation, etc.
- However, non-pregnant state” should be confirmed in urine pregnancy tests at screening visits.
8. Patients with history of severe cerebrovascular diseases (stroke, brain hemorrhage, etc.), hypertensive encephalopathy and transient ischemic attack (TIA) within 6 months prior to screening test.
9. Patients with severe heart diseases (heart failure of NYHA class III-IV), clinically significant valvular heart disease and patients who had myocardial infarction or unstable angina within 6 months prior to screening test.
10. Patients who had or had history of diseases, determined clinically significant by the investigators, of liver, kidneys, digestive system (biliary obstruction or cholestasis), respiratory, musculoskeletal, endocrine, neuropsychiatric, blood and tumor, urinary tract, cardiac arrhythmias and cardiovascular systems within 3 years prior to screening visits.
11. Patients who showed clinically significant abnormal kidney functions (creatinine 1.5 times more than the normal upper limit; creatinine clearance below 30ml/min) and abnormal liver functions (ALT or AST 3 times more than the normal upper limit).
12. Patients who had history of malignant tumors including leukemia and Lymphoma within the past 5 years (however, basal or squamous cell skin cancer are excluded).
13. Patients with contraindications and hypersensitivity against beta-blocker-based drugs.
14. Patients who are taking drugs (Ciroxin, etc.) that may affect Brachial-ankle pulse wave velocity.
15. Patients who experienced other clinical trials within 30 days prior to screening visits; patients who cannot stop taking medicine, other than the drugs for the clinical study, during the test period for hypertension or hyperlipidemia; or contraindicated drugs in combination or supplements that may affect the results of treating hypertension or hype

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified