The Japan Home vs. Office blood pressure Measurement Evaluation with AI <J-HOME AI> Multi-center randomized controlled study on efficacy of PREMINENT (losartan 50 mg/HCTZ 12.5 mg) and high-dose Angiotensin Receptor Blockers (ARBs) on home blood pressure / clinic blood pressure / augmentation index / central blood pressure in patients with uncontrolled hypertension under moderate-dose ARB monotherapy
Phase 4
- Conditions
- Hypertension
- Registration Number
- JPRN-UMIN000000964
- Lead Sponsor
- J-HOME AI Study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria 1) Secondary hypertension 2) Cardiac failure (above NYHA grade III) 3) Past history of major cardiac events or intervention (e.g., myocardial infarction, stroke) within 6 months prior to the start of the study. 4) Pregnancy (positive urine pregnancy test at pre-study) or breast feeding, or a female expecting to conceive within the study. 5) Critical liver damage 6) History of severe hepatic or renal disease (sCr>2.0 mg/dl) 7) Uncontrollable arrhythmia (atrial fibrillation, etc) 8) Hypersensitivity to ARB 9) Hypersensitivity to components of thiazide or similar compounds 10)Patient ineligible to this study due to other medical reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of various parameters measured at home, including home blood pressure and heart rate changes, during an eight-week treatment.
- Secondary Outcome Measures
Name Time Method - Clinic blood pressure, augmentation index, central blood pressure change in eight-week treatment. - Rate of achieving the target clinic blood pressure and home blood pressure at eight-week treatment. - Change in laboratory test results including LDL-C, K, sCr, uric acid, blood sugar, and HbA1c. - Safety of PREMINENT and maximum dose of ARBs - Sub-analysis