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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: quinapril

• Study Type: Observational
• Enrollment (Actual): 329

Contacts and Locations

Study Locations

• India
  • Bihar
    • Patna, Bihar, India, 01
      • Pfizer Investigational Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 015
      • Pfizer Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 003
      • Pfizer Investigational Site
    • Bangalore, Karnataka, India, 560 051
      • Pfizer Investigational Site
  • Maharashtra
    • Ahmedabad, Maharashtra, India, 380 015
      • Pfizer Investigational Site
    • Nagpur, Maharashtra, India, 440 015
      • Pfizer Investigational Site
    • Nagpur, Maharashtra, India, 440 033
      • Pfizer Investigational Site
    • Pune, Maharashtra, India, 411 004
      • Pfizer Investigational Site
  • New Delhi
    • Delhi, New Delhi, India, 110017
      • Pfizer Investigational Site
  • Rajasthan
    • Jaipur, Rajasthan, India, 302 020
      • Pfizer Investigational Site
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625003
      • Pfizer Investigational Site
    • Madurai, Tamil Nadu, India, 625014
      • Pfizer Investigational Site
  • Tamil nadu
    • Trichy, Tamil nadu, India, 620 021
      • Pfizer Investigational Site
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600 035
      • Pfizer Investigational Site
    • Madurai, Tamilnadu, India, 625 010
      • Pfizer Investigational Site
    • Madurai, Tamilnadu, India, 625 107
      • Pfizer Investigational Site
  • UttarPradesh
    • Kanpur, UttarPradesh, India, 208005
      • Pfizer Investigational Site
  • West Bengal
    • Kolkata, West Bengal, India, 20
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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®

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
quinapril	Drug: quinapril; per label as non interventional study; Other Names: Acupil®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12	Value at week 12 minus value at baseline.	Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12	Value at week 12 minus value at baseline.	Baseline and Week 12
Change From Baseline in SBP at Week 52	Value at week 52 minus value at baseline.	Baseline and Week 52
Change From Baseline in DBP at Week 52	Value at week 52 minus value at baseline.	Baseline and Week 52
Change From Pre-treatment in SBP at Week 0	Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.	Pre-treatment and Week 0
Change From Pre-treatment in DBP at Week 0	Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.	Pre-treatment and Week 0
Number of Participants Achieving BP Goal at Week 12	The status of achieving a participant's goal BP at Week 12 was yes (at goal) or no (not at goal). The BP goal also depended on the participant's status of "Diabetes Mellitus (DM) or renal disease". To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.	Week 12
Number of Participants With Achievement of BP Goal at Week 52	The status of achieving a participant's goal BP at week 52 was yes (at goal) or no (not at goal). The BP goal also depended on the participant's status of "DM or renal disease". To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.	Week 52
Duration of Monotherapy With Quinapril	Time in weeks to the first "taking additional antihypertensive medication" since Quinapril therapy began.	Baseline up to week 52 or early termination
Mean Daily Dose of Study Medication	The mean daily dose of the study medication was calculated by dividing the total dose (sum of the daily doses) in the study by the treatment duration.	Baseline up to week 52 or early termination
Number of Participants With Preference for add-on Anti-hypertensive Therapy	The first add-on antihypertensive therapy for each participant was the first additional antihypertensive medication since initiation of Quinapril. If the participant did not require any such add-on medication, the first add-on antihypertensive therapy was "None".	Baseline up to week 52 or early termination

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 29, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (Estimate): June 30, 2009

Study Record Updates

• Last Update Posted (Estimate): May 4, 2011
• Last Update Submitted That Met QC Criteria: April 7, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Quinapril non-interventional/observational study safety
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Quinapril
• Other Study ID Numbers: A9061066