You are here

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

Last updated on November 9, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Patna, Bihar, 01 India
Contact
1-800-718-1021
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Pulmonary Arterial Hypertension
NCT02060487
All Genders
18+
Years
Multiple Sites
Pulmonary Arterial Hypertension
NCT03364244
All Genders
0+
Years
Tokyo,
Descriptive Information
Brief TitleA Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population
Official TitleASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)
Brief SummaryThis 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Population400 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.
ConditionHypertension
InterventionDrug: quinapril
per label as non interventional study
Other Name: Acupil®
Study Groups/Cohortsquinapril
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 StatusCompleted
Actual Enrollment
 (submitted: August 18, 2010)
329
Original Estimated Enrollment
 (submitted: June 29, 2009)
400
Actual Study Completion DateJune 2010
Actual Primary Completion DateJune 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesIndia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00930722
Other Study ID NumbersA9061066
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now