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

NCT00930722

Last updated date
Study Location
Pfizer Investigational Site
Patna, Bihar, 01, India
Contact
1-800-718-1021

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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®

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Advanced Information
Descriptive Information
Brief Title A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population
Official Title ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)
Brief Summary 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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Hypertension
Intervention Drug: quinapril
per label as non interventional study
Other Name: Acupil®
Study Groups/Cohorts quinapril
quinapril
Intervention: Drug: quinapril
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 18, 2010)
329
Original Estimated Enrollment
 (submitted: June 29, 2009)
400
Actual Study Completion Date June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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®
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00930722
Other Study ID Numbers A9061066
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2011