Effect of a standard dose of telmisartan combined with amlodipine and trichlormethiazide versus a high dose of telmisartan combined with trichlormethiazide on urinary excretion of albumin in hypertensive patients with type 2 diabetes mellitus

Effect of a standard dose of telmisartan combined with amlodipine and trichlormethiazide versus a high dose of telmisartan combined with trichlormethiazide on urinary excretion of albumin in hypertensive patients with type 2 diabetes mellitus - Effect of a Standard dose of Telmisartan combIned with aMlodipine and trichlormethiazide versus a high dose of telmisArtan combined with Trichlormethiazide on urinary Excretion of Albumin in hypertensive patients with type 2 diabetes mellitus (ESTIMATE-A)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005170

Enrollment

Registered

2011-03-02

Start date

2011-03-01

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

Type 2 diabetic patients with essential hypertension and albuminuria

Interventions

ESTIMATE-A is a 6-months, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and albminuria are recruited and antihypertensive medications are ei

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

=30mg/g creatinine are enrolled. Then, patients are assigned to receive telmisartan (40mg/day) + amlodipine (5mg/day) + trichlormethiazide (1mg/day) for 6 months. In cases that the target blood pressu

130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level. Primary and secondary endpoints are evaluated at 3 and 6 months. After a 3-month run-in pe

=30mg/g creatinine are enrolled. Then, patients are assigned to receive telmisartan (80mg/day) + trichlormethiazide (1mg/day) for 6 months. In cases that the target blood pressure level (&lt

130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level. Primary and secondary endpoints are evaluated at 3 and 6 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetic patients with essential hypertension and albuminuria are recruited and are either started on or switched to telmisartan (40mg/day) + trichlormethiazide (1mg/day) for 3 months (run-in -period). Patients aged 20 years or older with BP >=130/80 mmHg and urinary excretion of albumin >=30mg/g creatinine at the end of run-in-period are finally enrolled.

Exclusion criteria

Exclusion criteria: Previous acute coronary syndrome, myocardial infarction, or stroke <6 months before informed consent; serum creatinine >1.5mg/dL (male) and >1.2mg/dL (female); serum potassium >=5.5mEq/L; office BP >=180/110mmHg; uncontrolled diabetes mellitus (HbA1c >=9.0%).

Design outcomes

Primary

Measure	Time frame
Changes in urinary excretion of albumin	—

Secondary

Measure	Time frame
Office BP, home BP, serum creatinine, serum uric acid, HbA1c, 24-h ABPM	—

Countries

Japan

Outcome results

None listed

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