NIPH Clinical Trials Search

UMIN ID: UMIN000000964

Registered date:04/01/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment2008/01/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
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


Primary OutcomeEvaluation 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 minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteriaExclusion 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


public contact
Name Junichiro Hashimoto
Address 6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN Japan
Telephone 022-795-6843
Affiliation Tohoku University Graduate School Department of Planning for Drug Development and Clinical Evaluation
scientific contact
Name Yutaka Imai
Address 6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN Japan
Telephone 022-795-6807
Affiliation Tohoku University Graduate School Department of Clinical Pharmacology and Therapeutics