A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population

NCT ID: NCT00930722

Last Updated: 2011-05-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-30

Brief Summary

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This is a prospective, non-interventional, non comparative drug study. The efficacy of Quinapril in Asian population has been evaluated, but specifically in Indian patients the data is sparse. Data in a real world setting in a large population of Indian patients would shed more light on the safety, tolerability and effectiveness of Quinapril in the Indian population.

Detailed Description

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Conditions

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Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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quinapril

quinapril

quinapril

Intervention Type DRUG

per label as non interventional study

Interventions

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quinapril

per label as non interventional study

Intervention Type DRUG

Other Intervention Names

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Acupil®

Eligibility Criteria

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Inclusion Criteria

* Patients already on therapy with Acupil® for a minimum period of 4 weeks, Evidence of a personally signed and dated informed consent document

Exclusion Criteria

* Patients having a Week 0 visit blood pressure reading of more than 180/110 mm of Hg will not be eligible to participate in the study.
* Women of child bearing age, not willing to use contraceptives, will not be eligible for the study
* Women using oral contraceptives will also not be included in the study
* Patients who have received any drug other than Acupil® as the first prescribed antihypertensive would not be eligible for enrollment into the trial
* Patients having any complication at Week 0 visit which would require more thorough investigations or who required more than one anti-hypertensive drug at the time of initiation of their therapy will not be included in the study
* Patients having any contraindications as per the LPD of Acupil®
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Patna, Bihar, India

Site Status

Pfizer Investigational Site

Ahmedabad, Gujarat, India

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Ahmedabad, Maharashtra, India

Site Status

Pfizer Investigational Site

Nagpur, Maharashtra, India

Site Status

Pfizer Investigational Site

Nagpur, Maharashtra, India

Site Status

Pfizer Investigational Site

Pune, Maharashtra, India

Site Status

Pfizer Investigational Site

Delhi, New Delhi, India

Site Status

Pfizer Investigational Site

Jaipur, Rajasthan, India

Site Status

Pfizer Investigational Site

Chennai, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Madurai, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Madurai, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Madurai, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Madurai, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Trichy, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Kanpur, Uttar Pradesh, India

Site Status

Pfizer Investigational Site

Kolkata, West Bengal, India

Site Status

Countries

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India

Related Links

Other Identifiers

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A9061066

Identifier Type: -

Identifier Source: org_study_id

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