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Assessment of suitable Antihypertensive therapies: Combination with high dose amlodipine/Irbesartan vs. triple combination with amlodipine/Irbesartan/Indapamide

Assessment of suitable Antihypertensive therapies: Combination with high dose amlodipine/Irbesartan vs. triple combination with amlodipine/Irbesartan/Indapamide - ASAHI-AI study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013343
Enrollment
160
Registered
2014-03-06
Start date
2014-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Increased Ca channel blocker regimen group Up to 12 weeks: Irbesarten100mg/amlodipine 10mg From 12 weeks to 24 weeks: antihypertensive drugs other than ARBs, Ca channel blockers, and diuretics are a

Sponsors

Asahikawa Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with essential hypertension, who have been previously treated with ARBs and Ca channel blockers (Irbesartan 100mg/Amlodipine 5mg or usual dosage of ARBs/Amlodipine 5mg) and whose blood pressure has not been adequately controlled with the treatment ( SBP>=140mmHg and /or DBP>=90mmHg). 2) Age more than 20 and less than 85 years 3) Outpatients 4) Patients understand the study procedures and agree to participate in the study by giving written informed consent prior to the start of the study.

Exclusion criteria

Exclusion criteria: 1) Patients with secondary hypertension 2) Patients with a history of severe renal disease: serum creatinine>2.0 mg/dl 3) Patients with critical liver damage (AST or ALT>100 IU/l) 4) Patients with a history of adverse effects to ARBs 5) Bilateral renal artery stenosis 6) Patients with hyperkalemia >=5.5 mEq/L 7) Patients with pregnancy or breast-feeding 8) Patients with a poor prognosis such as a malignant tumor 9) Patients who are considered not to be eligible for the study by the investigator due to medical reasons

Design outcomes

Primary

MeasureTime frame
Systolic/Diastolic blood pressure change after a 12 week treatment

Secondary

MeasureTime frame
Blood pressure change (home blood pressure monitoring in the morning and at night) Change in the ambulatory blood pressure (ABPM) The rate of achieving the target blood pressure Change in the laboratory data Systolic/Diastolic blood pressure change after a 24 week treatment The rate of continued treatment and the compliance of the treatment at 24 weeks

Countries

Japan

Contacts

Public ContactNobuyuki Sato

Asahikawa Medical University Cardiovascular Respiratory and Neurology Division, Department of Internal Medicine

nsato@asahikawa-med.ac.jp0166-68-2442

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026