An increase dose of CCB or ARB as an add-on intensive DEpressor therapy in type 2 diabetes MellItus patients with uncontrolled Essential hypertension.

An increase dose of CCB or ARB as an add-on intensive DEpressor therapy in type 2 diabetes MellItus patients with uncontrolled Essential hypertension. - Intensive depressor therapy in diabetes mellItus patients with hypertension (ACADEMIE Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021594

Enrollment

120

Registered

2016-03-24

Start date

2016-03-24

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

Hypertension

Interventions

The patients with hypertension under treatment with middle dose of ARB + amlodipine 5 mg/day are enrolled. The patients receive a middle dose of ARB + amlodipine 10 mg/day and treated for 12 weeks. Th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with diabetes mellitus according to the Japan Diabetes Society guideline 2.Patients with essential hypertension who had SBP = or > 130 mmHg and/or DBP = or > 80 mmHg and received a middle dose of ARB + amlodipine 5 mg/day at least for 4 weeks. 3.Age is 20 years old or more. 4.Patients who gave their informed consent to participate for the present study.

Exclusion criteria

Exclusion criteria: 1.The patients with secondary hypertension 2.The patients who had SBP < 130 mmHg and DBP < 80 mmHg before starting the study 3.Severe liver dysfunction. 4.Severe renal dysfunction. 5.Pregnancy or lactation in women. 6.Patients with a history of allergy to any component of the study medications. 7.Patients corresponding to the contraindication of study medications. 8.Participating in other clinical trials or within 3 months after retirement of prior clinical trial, 9.Ineligible based on the judgment of the physician

Design outcomes

Primary

Measure	Time frame
Changes in home systolic BP early in the morning between at baseline and after 12 weeks	—

Secondary

Measure	Time frame
Changes in various parameters between at baseline and after 12 weeks as follows (No. 1-14): 1.Home diastolic BP early in the morning 2.Office BP 3.Home BP before going to the bed 4.Home BP in sleeping 5.Percentage of the patients who reach the target BP (Office BP and BP early in the morning) 6.Variability and coefficient of BP 7.Brachial-ankle pulse wave veocity 8.High-sensitivity C reactive protein 9.Pentraxin-3 10.Adiponectin 11.Brain natriuretic peptide 12.Urinary albumin 13.Cystatin C 14.L-FABP 15.Side effects	—

Measure

Time frame

Changes in various parameters between at baseline and after 12 weeks as follows (No. 1-14): 1.Home diastolic BP early in the morning 2.Office BP 3.Home BP before going to the bed 4.Home BP in sleeping 5.Percentage of the patients who reach the target BP (Office BP and BP early in the morning) 6.Variability and coefficient of BP 7.Brachial-ankle pulse wave veocity 8.High-sensitivity C reactive protein 9.Pentraxin-3 10.Adiponectin 11.Brain natriuretic peptide 12.Urinary albumin 13.Cystatin C 14.L-FABP 15.Side effects

—

Countries

Japan

Contacts

Public ContactShin-ichiro Miura

Fukuoka University Hospital Department of Cardiology

miuras@cis.fukuoka-u.ac.jp81-92-801-1011

Outcome results

None listed

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