Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus

Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus - Mechanisms of antiproteinuric effects of AzelnidiPine IN hypertensive patients with type 2 Diabetes Mellitus (MAP in DM)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007456

Enrollment

Registered

2012-03-08

Start date

2012-03-01

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

Essential hypertension with type 2 diabetes mellitus and proteinuria

Interventions

MAP in DM is a 12-week, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and proteinuria are recruited and antihypertensive medications are eit

130/80mmHg and urinary excretion of albumin =&gt

300mg/g creatinine are enrolled. Then, patients are randomly assigned to receive either azelnidipine (16mg/day) or amlodipine (5mg/day) in combination with a standard dose of an angiotensin receptor b

130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level. MAP in DM is a 12-week, prospective, randomized, open, blinded-endpoint (PROBE) study. Ty

130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetic patients with essential hypertension and proteinuria are recruited and are either started on or switched to a monotherapy with a standard dose of an angiotensin receptor blocker for 3 months (run-in -period). Patients with BP =>130/80 mmHg and urinary excretion of albumin =>300mg/g creatinine at the end of run-in-period are finally enrolled.

Exclusion criteria

Exclusion criteria: Exclusion criteria are: secondary hypertension; history of acute coronary syndrome, heart failure, coronary revascularization, or stroke within the previous 6 months; uncontrolled diabetes mellitus (HbA1c >9.0%); confirmed or suspected renal artery stenosis; serum creatinine of 1.5mg/dl or more for men and 1.2mg/dl or more for women; contraindication to calcium channel blockers; pregnant women; or clinic systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg.

Design outcomes

Primary

Measure	Time frame
(1)Changes in urinary excretion of albumin from baseline to 1, 2, 4, 12 weeks after randomization (2)Changes in blood pressure and heart rate from baseline to 1, 2, 4, 12 weeks after randomization (3)Changes in urine L-FABP, OHdG, sodium, and metanephrine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine (4)Changes in serum creatinine, hs-CRP, IL-6, ADMA, cystatin C, and pentosidine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine (5)Relationship of (1) with (2) , (3), (4), (5)	—

Measure

Time frame

(1)Changes in urinary excretion of albumin from baseline to 1, 2, 4, 12 weeks after randomization (2)Changes in blood pressure and heart rate from baseline to 1, 2, 4, 12 weeks after randomization (3)Changes in urine L-FABP, OHdG, sodium, and metanephrine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine (4)Changes in serum creatinine, hs-CRP, IL-6, ADMA, cystatin C, and pentosidine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine (5)Relationship of (1) with (2) , (3), (4), (5)

—

Secondary

Measure	Time frame
home BP, HbA1c	—

Countries

Japan

Contacts

Public ContactMasayoshi Kojima

Komono Kosei Hospital Department of Internal Medicine

m-kojima@kkh.miekosei.or.jp059-393-1212

Outcome results

None listed

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