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Branded versus branded generic amlodipine in hypertensio

Phase 4
Conditions
Health Condition 1: null- essential Hypertension
Registration Number
CTRI/2015/01/005390
Lead Sponsor
IPGMER
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
28
Inclusion Criteria

1. Subjects with Stage-I Hypertension of JNC-7 Classification i.e. Systolic Blood Pressure (SBP) of 140-159 mm of hg or Diastolic Blood Pressure(DBP) of 90-99 mm of hg who were not receiving any antihypertensive in the last 1 week before screening

OR

Subjects with Isolated systolic hypertension as per JNC 7 Classification i.e. Systolic Blood Pressure (SBP) of >= 140 mm of hg and Diastolic Blood Pressure (DBP) of < 90 mm of hg who were not receiving any antihypertensive medicines in the last 1 week prior to screening

2.Age >= 18 but <= 70 years of either sex

3.Subjects willing to give written informed consent and abide by all study related procedures

Exclusion Criteria

(1)Subjects with blood pressure values out of range

(2)Past history of hypersensitivity to Amlodipine

(3)Female subjects who are pregnant or lactating

(4)Any clinical condition that may be considered as unsuitable for study inclusion

(5)Presence of any clinical condition that is contraindicated for Amlodipine use

(6)History of pre-existing liver diseases or renal diseases

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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