Renoprotective effects of azelnidipine in hypertensive diabetic patients in Mie

Renoprotective effects of azelnidipine in hypertensive diabetic patients in Mie - RANDAM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003451

Enrollment

146

Registered

2010-04-06

Start date

2010-02-01

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

RANDAM is a 24-week, prospective, randomized, open, blinded-endpoint (PROBE) study. After a screening phase for eligibility, inhibitors of the renin-angiotensin system, calcium channel blockers, and d

130/80mmHg. Data are obtained at 12- and 24-week. The target of glycemic levels is HbA1c of less than 6.5%. The addition of a thiazolidinedione is not allowed during the study period. After a screenin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hypertensive patients with type 2 diabetes mellitus and albuminuria (30-600mg/g creatinine) with clinic blood pressure >130/80mmHg under a monotherapy with a standard dosage of an inhibitor of the renin-angiotensin system.

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%); a disorder that requires treatment with calcium channel blockers or diuretics; confirmed or suspected renal artery stenosis; serum creatinine of 2.0mg/dl or more for men and 1.5mg/dl or more for women; pregnant women; or clinic systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg.

Design outcomes

Secondary

Measure	Time frame
(1) The change in the urine Alb/Cr ratio from baseline to week 12. (2) The change in estimated glomerular filtration ratio from baseline to week 12 and 24. (3) Proportion of patients who progress to overt diabetic nephropathy (4) The magnitude of albuminuria (5) The changes in serum creatinine, potassium, sodium, LDL-cholesterol, HDL-cholesterol, and HbA1c levels (6) The changes in urine excretion of sodium (7) The changes in clinic blood pressure and heart rate (8) The changes in self-measured blood pressure at home	—

Measure

Time frame

(1) The change in the urine Alb/Cr ratio from baseline to week 12. (2) The change in estimated glomerular filtration ratio from baseline to week 12 and 24. (3) Proportion of patients who progress to overt diabetic nephropathy (4) The magnitude of albuminuria (5) The changes in serum creatinine, potassium, sodium, LDL-cholesterol, HDL-cholesterol, and HbA1c levels (6) The changes in urine excretion of sodium (7) The changes in clinic blood pressure and heart rate (8) The changes in self-measured blood pressure at home

—

Primary

Measure	Time frame
Primary endpoint is the change in the ratio of urine albumin to creatinine (Alb/Cr) from baseline to week 24.	—

Countries

Japan

Outcome results

None listed

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