Study to compare the effect of benidipine and amlodipine on blood pressure and renal function in patients with type 2 diabetes mellitus and hypertension treated with angiotensin 2 receptor antagonists

Study to compare the effect of benidipine and amlodipine on blood pressure and renal function in patients with type 2 diabetes mellitus and hypertension treated with angiotensin 2 receptor antagonists - Comparison of benidipine and amlodipide in DM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003315

Enrollment

Registered

2010-04-01

Start date

2010-05-01

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

type 2 diabetes mellitus with hypertension

Interventions

benidipine 4mg amlodipine 2.5mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) type 2 diabetic patients with hypertension not attaining the goal of JSH2009 2) Urinary albumin/creatinine > or = 30mg/gCr 3) Serum creatinine < or = 2.0mg/dl

Exclusion criteria

Exclusion criteria: 1) Patients with cerebro-cardiovascular disease, such as unstable angina, acute myocardial infarction, and stroke within 6 months 2) Patients with congestive heart failure or severe arrhythmia 3) Patients with severe liver dysfunction 4) Patients with severe renal dysfunction or nephrotic syndrome 5) Pregnant patients 6) Patients allergic to benidipine or amlodipine

Design outcomes

Primary

Measure	Time frame
Urinary albumin/creatinine ratio	—

Secondary

Measure	Time frame
1) Blood pressure 2) urinary protein/creatinine, eGFR 3) safety	—

Countries

Japan

Contacts

Public ContactNoriyuki Iehara

Kyoto University Graduate School of Medicine Department of nephrology

niehara@kuhp.kyoto-u.ac.jp075-751-3110

Outcome results

None listed

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