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

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NCT00930722

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Patna, Bihar, 01 India
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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®

NCT00930722
Pfizer
Completed
A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population

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[email protected]

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A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population
ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
400 patients will be included in this non-interventional study. Only hypertensive subjects, over the age of 18 years, and who have already been receiving Acupil® for a minimum duration of 4 weeks will be included in the study.
Hypertension
Drug: quinapril
per label as non interventional study
Other Name: Acupil®
quinapril
quinapril
Intervention: Drug: quinapril
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
329
June 2010
June 2010   (Final data collection date for primary outcome measure)

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®
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00930722
A9061066
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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