Combination effects of an angiotensin receptor blocker and an L/T type calcium channel blocker in hypertensive patients with type 2 diabetes mellitus

Combination effects of an angiotensin receptor blocker and an L/T type calcium channel blocker in hypertensive patients with type 2 diabetes mellitus - COmbination Effects of an angiotensin receptor blocker and an L/T type calcium chaNnel blocker in hypertensive patients with type 2 diabetes mellitus (COEN)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007463

Enrollment

Registered

2012-03-07

Start date

2011-12-01

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

Essential hypertension with type 2 diabetes mellitus and albuminuria

Interventions

COEN is a 12-month, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and albuminuria under a monotherapy with an angiotensin receptor blocker a

10mg/g creatinine and blood pressure =&gt

130/80mmHg are enrolled. Then, patients are randomly assigned to receive either benidipine (4mg/day) or amlodipine (5mg/day) in addition to an angiotensin receptor blocker for 12 months. Patients are

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus Essential hypertension Urinary excretion of albumin =>10mg/g creatinine and office systolic blood pressure =>130mmHg and/or diastolic blood pressure =>80mmHg under a monotherapy with a standard dose of angiotensin recptor blockers

Exclusion criteria

Exclusion criteria: Previous acute coronary syndrome, myocardial infarction, or stroke within 6 months; malignant neoplasm; heart failure (=>NYHA 2); peripheral artery disease (=>Fontaine 2); chronic inflammatory disease; hepatic disorder; estimated glomerular filtration rate <30 ml/min/1.73m2; contraindication to calcium channel blockers

Design outcomes

Primary

Measure	Time frame
Changes in urinary excretion of albumin from baseline to 12 months after randomization	—

Secondary

Measure	Time frame
1. Changes in blood pressure and pulse rate 2. Changes in serum creatinine and glomerular filtration rate 3. Changes in NT-pro BNP and CRP 4. Correlation of changes in urinary excretion of albumin with other secondary outcomes 5. Adverse Effects	—

Countries

Japan

Contacts

Public ContactYasuaki Dohi

Nagoya City University Graduate School of Medical Sciences Cardio-Renal Medicine and Hypertension

ydohi@med.nagoya-cu.ac.jp052-853-8221

Outcome results

None listed

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