Azilsartan Circadian and Sleep pressure the 1st study

Not Applicable

• Conditions: Grade I or Grade II essential hypertension patients

• Registration Number: JPRN-UMIN000009576
• Lead Sponsor: ACS Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-18
• Study Completion: 2013-11-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

A. Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180mmHg or sitting diastolic blood pressure greater than or equal to 110mmHg), malignant hypertension B. More than 2 kinds of hypotensive agents for treatment on the hypertension C. History of taking following within 2 weeks before start of the observation period When subject taking any of the following at the time of informed consent is included, stop to take the medicine for determined period after the informed consent. a. Hypotensive agents b. Antianginal agents c. Antiarrhythmic agents (except single time use of the lidocaine hydrochloride formulation for anesthesia) d. Digitalis products D. Less than 130mmHg of mean 24-hour systolic blood pressure and less than 80mmHg of mean 24-hour diastolic blood pressure at the start of the observation period. E. History of following circulatory-related diseases or symptoms within 24 weeks before start of the observation period a. Cardiac disease: Myocardial infarction, coronary artery revascularization b. Cerebrovascular disease: cerebral infarction, cerebral hemorrhage, transient ischemic attack c. Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema F. History or complication with the following circulatory-related diseases Valvular stenosis, Atrial fibrillation, pharmacotherapy-required angina, congestion heart failure, or cardiac arrhythma, or arteriosclerosis obliterans with symptoms of intermittent claudication et al G. Day/night reversal H. History of hypersensitivity or allergy to Azilsartan, Amlodipine, or related drugs I. Participant in any other clinical research J. Pregnant, possible to pregnancy, or lactating woman K. Mal-control of blood pressure during informed consent to taking hypotensive agent L. Symptoms or abnormalities require the withdrawal as soon as possible during informed consent to taking hypotensive agent M. Any those the investigator or other researchers consider as unsuitable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in nocturnal systolic blood pressure level* -Change at the end of a treatment period (Week8) from the beginning point of an observation period * : -- nocturnal systolic blood pressure level: -- the mean value of systolic arterial pressure during night (during sleeping)