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

UMIN ID: UMIN000000964

Registered date:04/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2008/01/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

- Titration to high-dose ARBs (losartan 100mg, candesartan 12mg, valsartan 160mg, telmisartan 80mg, olmesartan 40mg) - Once daily - Treatment period: 8 weeks
- Change to Preminent (losartan 50mg/HCTZ 12.5mg) - Once daily - Treatment period: 8 weeks

Outcome(s)

• Primary Outcome: Evaluation of various parameters measured at home, including home blood pressure and heart rate changes, during an eight-week treatment.
• Secondary Outcome: - 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: J-HOME AI Study group
• Source(s) of Monetary Support: Miyagi Kidney foundation