MedPath

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

Not Applicable
Conditions
Essential hypertension
Registration Number
JPRN-UMIN000002144
Lead Sponsor
agano Kidney Evaluation Association (NKEA)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change of diastolic blood pressure from baseline in trough and sitting position
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath