Assessment of efficacy and safety profile of irbesartan/amlodipine single-pill combination drug in uncontrolled-hypertension with type 2 diabetic patients.

Assessment of efficacy and safety profile of irbesartan/amlodipine single-pill combination drug in uncontrolled-hypertension with type 2 diabetic patients. - Aimix study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010266

Enrollment

Registered

2013-03-18

Start date

2013-03-06

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 with type 2 diabetes

Interventions

Switching ABR and CCB, which patients are already taking, to irbesartan/amlodipine single-pill combination drug. Other anti-hypertensive and anti-diabetic medications are maintained at the same dosage

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are a baseline systolic blood pressure &#8805;130 or diastolic blood pressure &#8805;80 mmHg on medical examination in the patients who are taking antihypertensive agents, including ARB and CCB for more than one month.

Exclusion criteria

Exclusion criteria: The exclusion criteria are based on fulfillment of at least one of the following; 1) a past history of allergy of this medicine or dihydropyridine drugs; 2) pregnancy, possibility of pregnancy; 3) current treatment with corticosteroids and/or immnosuppressive drugs; 4) patients who judge that the physician is not suitable

Design outcomes

Primary

Measure	Time frame
Change of the blood pressure on medical examination	—

Secondary

Measure	Time frame
Urinary albumin Serum creatinine eGFR Serum uric acid Serum potassium HbA1c Pntraxin3	—

Countries

Japan

Outcome results

None listed

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