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)”

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.

Intervention(s) in this Clinical Trial

• Drug: quinapril
  • per label as non interventional study

Arms, Groups and Cohorts in this Clinical Trial

• : quinapril
  • quinapril

Primary Measures

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Time Frame: Baseline to Week 52
    Safety Issue?: Yes

Secondary Measures

• Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Change From Baseline in SBP at Week 52
  • Time Frame: Baseline and Week 52
    Safety Issue?: No
• Change From Baseline in DBP at Week 52
  • Time Frame: Baseline and Week 52
    Safety Issue?: No
• Change From Pre-treatment in SBP at Week 0
  • Time Frame: Pre-treatment and Week 0
    Safety Issue?: No
• Change From Pre-treatment in DBP at Week 0
  • Time Frame: Pre-treatment and Week 0
    Safety Issue?: No
• Number of Participants Achieving BP Goal at Week 12
  • Time Frame: Week 12
    Safety Issue?: No
• Number of Participants With Achievement of BP Goal at Week 52
  • Time Frame: Week 52
    Safety Issue?: No
• Duration of Monotherapy With Quinapril
  • Time Frame: Baseline up to week 52 or early termination
    Safety Issue?: No
• Mean Daily Dose of Study Medication
  • Time Frame: Baseline up to week 52 or early termination
    Safety Issue?: No
• Number of Participants With Preference for add-on Anti-hypertensive Therapy
  • Time Frame: Baseline up to week 52 or early termination
    Safety Issue?: No

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®

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930722

Study ID Number: A9061066

ClinicalTrials.gov Identifier: NCT00930722

Health Authority: India: Institutional Review Board

To obtain contact information for a study center near you, click here.