Hypertension
Conditions
Interventions
- 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/HCT
Sponsors
J-HOME AI Study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria for study patients: 1) Out-patient with essential hypertension, who has been previously treated with moderate-dose ARB monotherapy and whose blood pressure has not been adequately controlled with the treatment - Patient has received one of five ARB monotherapies (either Losartan 50 mg, Candesartan 8 mg, Valsartan 80 mg, Telmisartan 40 mg, or Olmesartan 20 mg) at least for 4 weeks. - Untreated patient at -4 weeks, with a clinic SBP >=140 mmHg and/or DBP >90mmHg - Average home morning SBP >=135 mmHg at 0 week 2) Between 20 and 80 years of age 3) Gender is not restricted. 4) Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of various parameters measured at home, including home blood pressure and heart rate changes, during an eight-week treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Japan
Contacts
Public ContactJunichiro Hashimoto
Tohoku University Graduate School Department of Planning for Drug Development and Clinical Evaluation
Outcome results
None listed