Efficacy and safety of a single-pill fix dose combination of azilsartan and amlodipine

Efficacy and safety of a single-pill fix dose combination of azilsartan and amlodipine - 4A study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016251

Enrollment

Registered

2015-01-17

Start date

2014-07-01

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

Hypertension

Interventions

The patients receive a single-pill fixed-dose combination of a single-pill fixed-dose combination of azilsartan/amlodipine and treated for 16 weeks. If the patient dose not reach the target office blo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with hypertension who receive a single-pill fixed-dose combination of valsartan/amlodipine or irbesartan/amlodipine 2.Age is 20 years old or more. 3.Patients who give their informed consent to participate for the present study.

Exclusion criteria

Exclusion criteria: 1.Severe liver dysfunction. 2.Severe renal dysfunction. 3.Pregnancy or lactation in women. 4.Patients with a history of allergy to any component of the study medications. 5.Patients corresponding to the contraindication of study medications. 6.Ineligible patients according to the judgment by physician.

Design outcomes

Primary

Measure	Time frame
Depressor effects at office blood pressure	—

Secondary

Measure	Time frame
1.The percentage of patients who reach the target office blood pressure. 2.Changes in biochemical parameters in blood and urine.	—

Countries

Japan

Contacts

Public ContactShin-ichiro Miura

Fukuoka University School of Medicine 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