Study of assessment for vascular endothelial function and renal function with irbesartan or amlodipine in hypertensive patients with proteinuria - prospective randomized controlled trial -

Study of assessment for vascular endothelial function and renal function with irbesartan or amlodipine in hypertensive patients with proteinuria - prospective randomized controlled trial - - Study of assessment for vascular endothelial function and renal function with irbesartan or amlodipine in hypertensive patients with proteinuria - prospective randomized controlled trial -

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004569

Enrollment

Registered

2010-11-16

Start date

2010-11-01

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 with proteinuria

Interventions

irbesartan amlodipine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) hypertensive patients, 2) urinary albumin-creatinine ratio 30mg/g*Cr or more within 6 months, 3) estimated glomerular filtration rate 70mL/min/1.73m2, 4) ambulatory systolic and/or diastolic blood pressure 130/80 mmHg or more, 5) written informed consent

Exclusion criteria

Exclusion criteria: 1) history of anaphylaxis of irbesartan or amlodipine, 2) patients who did not receive an antihypertensive treatment with angiotensin II receptor blockers (ARB), angiotensin converting enzyme (ACE) inhibitors or rennin inhibitor before the enrollment, 3) secondary hypertension, 4) history of stroke, myocardial infarction or cardiovascular disease, 5) nephrosis, 6) genetic renal disease, 7) patients with nephritis treated by corticosteroids, 8) hepatic dysfunction, 9) moderate heart failure (New York heart Association classes II or more), 10) patients with cancer or severe disease, 11) uncontrolled diabetic mellitus (HbA1c 8.0% or more), 12) bronchial asthma, 13) pregnancy, 14) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Design outcomes

Primary

Measure	Time frame
Change in coronary vascular resistance measured by a PET (positron-emission tomography)	—

Secondary

Measure	Time frame
1) inulin clearance, 2) ambulatory blood pressure and heart rate, 3) blood test, urinary test and biomarker, 4) change in Flow mediated dilatation (FMD), 5) safety parameter	—

Countries

Japan

Contacts

Public ContactSaori Nishio

Hokkaido University Hospital Department of Medicine II

saorin@med.hokudai.ac.jp011-706-5915

Outcome results

None listed

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