A clinical study of amlodipine besilate OD tablet for the essential hypertension patients - Comparative study on the antihypertensive effect and the safety between a bland drug and a generic drug -

A clinical study of amlodipine besilate OD tablet for the essential hypertension patients - Comparative study on the antihypertensive effect and the safety between a bland drug and a generic drug - - A comparative study on the efficacy and safety between a bland drug and a generic drug of the amlodipine besilate OD tablet

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002144

Enrollment

100

Registered

2009-07-01

Start date

2009-07-01

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

Essential hypertension

Interventions

amlodipine besilate OD tablet (a generic drug) 2.5 mg or 5 mg amlodipine besilate OD tablet (a bland drug) 2.5 mg or 5 mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Essential hypertension Grade I and II patients diagnosed according to the Hypertension Treatment Guideline 2009 of the Japanese Society of Hypertension 2.Patients who have been taking amlodipine besilate regular tablets (2.5 or 5 mg, single daily) for more than 8 weeks 3.Patients whose diastolic blood pressure has been kept between >=70 mmHg and <110 mmHg for 2 months 4.Patients whose written consent is obtained at age 20 years or over, etc

Exclusion criteria

Exclusion criteria: 1.Patients who take calcium channel blocker except amlodipine besilate regular tablets 2.Grade III hypertension 3.Secondary hypertension 4.Malignant hypertension 5.Patients with hepatic dysfunction or severe hepatic disease 6.Patients with a past history of hypersensitiveness to the study drug 7.Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period 8.Patients with malignant cancer 9.Patients with a past history of drug abuse or drug addiction 10.Patients who have attended toany clinical trials within 12 months before the start of the administration, etc

Design outcomes

Primary

Measure	Time frame
Change of diastolic blood pressure from baseline in trough and sitting position	—

Countries

Japan

Outcome results

None listed

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