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 -

UMIN ID: UMIN000002144

Registered date:01/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Essential hypertension
• Date of first enrollment: 2009/07/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Change of diastolic blood pressure from baseline in trough and sitting position

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Nagano Kidney Evaluation Association (NKEA)
• Source(s) of Monetary Support: Nichi-Iko Pharmaceutical Co.,Ltd.