EARLY-NH study
- Conditions
- octurnal hypertension
- Registration Number
- JPRN-jRCTs031200364
- Lead Sponsor
- Kario Kazuomi
- Brief Summary
The amount of change in nocturnal blood pressure using the brachial sphygmomanometer, which is the primary endpoint, shown a statistically significant decrease in both systolic and diastolic blood pressure. A statistically significant decrease was also shown in home blood pressure early morning and before bedtime, and in consultation room blood pressure. No serious adverse reactions were reported and no new adverse events/adverse reactions requiring confirmation were noted in the safety evaluation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 101
1) Patients aged 20 years or older at informed consent
2) Patients administered ARB or CCB
3) Patients with a nocturnal systolic BP of at least 120 mmHg
1) Patients diagnosed with secondary hypertension or malignant hypertension
2) Patients with hyperkalemia or serum potassium levels exceeding 5.0 mEq/L
3) Patients with any cerebro-cardiovascular diseases
4) Patients who used prohibited concomitant medications
5) Patients with severely impaired renal function (eGFRcreat < 30 mL/min/1.73 square meter)
6) Patients with seriously impaired hepatic function (e.g., hepatic failure and hepatic cirrhosis)
7) Patients with a life expectancy within 1 year due to some disease
8) Patients with a history of serious drug allergies
9) Pregnant, possibly pregnant, breast-feeding or planning to become pregnant
10) Patients working the night shift at least 3 days a week in a shift-work system
11) Patients deemed otherwise unsuitable for the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Evaluation<br>Change from baseline in nocturnal BP (systolic BP and diastolic BP)
- Secondary Outcome Measures
Name Time Method