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    Prakash Gupta
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    This document provides a synopsis of the ADMAC study, a 2-year prospective, interventional study conducted across multiple sites in Ahmedabad and Vadodara, India. The study aimed to observe adverse drug reactions and clinical efficacy of angiotensin-converting enzyme inhibitor drugs in 120 subjects aged 20-70 with stage 1 or 2 essential hypertension. Study participants were given the interventional drug by investigators and any adverse drug reactions recorded on case report forms which were collected at study completion for analysis.

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    This document provides a synopsis of the ADMAC study, a 2-year prospective, interventional study conducted across multiple sites in Ahmedabad and Vadodara, India. The study aimed to observe adverse drug reactions and clinical efficacy of angiotensin-converting enzyme inhibitor drugs in 120 subjects aged 20-70 with stage 1 or 2 essential hypertension. Study participants were given the interventional drug by investigators and any adverse drug reactions recorded on case report forms which were collected at study completion for analysis.

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    6 views1 page

    ADR Reporting

    Uploaded by

    Prakash Gupta
    This document provides a synopsis of the ADMAC study, a 2-year prospective, interventional study conducted across multiple sites in Ahmedabad and Vadodara, India. The study aimed to observe adverse drug reactions and clinical efficacy of angiotensin-converting enzyme inhibitor drugs in 120 subjects aged 20-70 with stage 1 or 2 essential hypertension. Study participants were given the interventional drug by investigators and any adverse drug reactions recorded on case report forms which were collected at study completion for analysis.

    Copyright:

    Attribution Non-Commercial (BY-NC)
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    of 1

    Version No: 01

    ADR SYNOPSIS
    Title Adverse drug reaction monitoring of
    Angiotensin-Converting Enzyme
    Inhibitor drug

    Acronym ADMAC study


    Study location Ahmedabad, Vadodara
    Study sites Multicentric
    Study period 2 years
    Study design Prospective, interventional study
    Study methodology • Interventional drug is given to the
    investigator
    • By investigator , it will be given
    to the subjects
    • Then, if there is any ADRs ,it will
    be recorded on CRFs
    • Finally, collection of all CRFs
    after completion
    Primary study Objective To observe the associated ADR of ACE
    inhibitor drug along with its clinical
    efficacy
    Sample size 120 subjects
    Inclusion criteria Age 20 yrs to 70 yrs
    Stage 1 and 2 essential hypertension
    Exclusion criteria Kidney transplantation, dialysis and
    other co morbid condition or
    complication
    Statistical analysis Data were analyzed according to
    participants’ treatment assignments
    regardless of their subsequent
    medications (intent to-treat analysis).

    April 1, 2011 Page 1

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