Comparison of azelnidipine and trichlormethiazide in Japanese type 2 diabetic patients with hypertension: the COAT randomized controlled trial

Comparison of azelnidipine and trichlormethiazide in Japanese type 2 diabetic patients with hypertension: the COAT randomized controlled trial - the COAT randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006081

Enrollment

240

Registered

2011-07-30

Start date

2011-08-01

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 hypertension

Interventions

Treatment with azelnidipine (16mg/day). Collection of blood and urine at 0, 24 and 48 weeks after administration of the agent. Treatment with trichlormethiazide (1mg/day). Collection of blood and urin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with adequately controlled diabetes (HbA1c < 7.0%) and inadequately controlled hypertension (systolic blood pressure [sBP] < 130 mmHg or diastolic blood pressure [dBP] < 80 mmHg) who were being treated with olmesartan.

Exclusion criteria

Exclusion criteria: 1. Patients with history of diabetic ketoacidosis, or diabetic coma within 6 months prior to the study entry. 2. Patients who received other antidiabetic within 3 months prior to the study entry. 3. Patients who received surgical operation during the study. 4. Patients with severe infection or severe trauma. 5. Patients with during pregnancy or lactation. 6. Patients with severe liver dysfunction. 7. Patients with severe renal dysfunction. 8. Patients who received insulin therapy. 9. Patients who received steroid therapy. 10. Patients with history of hypersensitivity reaction to azelnidipine or trichlormethiazide. 11. Patients determined to be inappropriate by physician.

Design outcomes

Primary

Measure	Time frame
Main outcome measure was the difference in the change in HbA1c levels from the baseline values at 48 weeks between these two groups.	—

Secondary

Measure	Time frame
Key secondary outcomes were the levels of sBP, dBP, fasting plasma glucose (FPG), fasting insulin (FI), inflammation mediators, adiponectin, and markers of lipids, uric acid, liver function and renal function. Frequency of side effects such as vertigo, dizziness, and edema after administration of azelnidipine or trichlormethiazide.	—

Countries

Japan

Contacts

Public ContactMasahiro Takihata

Yokohama City Unuversity School of Medicine Department of Endcrinology & Metabolism

0457872800

Outcome results

None listed

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