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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00930722
First received: June 29, 2009
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Hypertension
Drug: quinapril

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Value at week 12 minus value at baseline.

  • Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Value at week 12 minus value at baseline.

  • Change From Baseline in SBP at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Value at week 52 minus value at baseline.

  • Change From Baseline in DBP at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Value at week 52 minus value at baseline.

  • Change From Pre-treatment in SBP at Week 0 [ Time Frame: Pre-treatment and Week 0 ] [ Designated as safety issue: No ]
    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.

  • Change From Pre-treatment in DBP at Week 0 [ Time Frame: Pre-treatment and Week 0 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Achieving BP Goal at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Achievement of BP Goal at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.

  • Duration of Monotherapy With Quinapril [ Time Frame: Baseline up to week 52 or early termination ] [ Designated as safety issue: No ]
    Time in weeks to the first "taking additional antihypertensive medication" since Quinapril therapy began.

  • Mean Daily Dose of Study Medication [ Time Frame: Baseline up to week 52 or early termination ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Preference for add-on Anti-hypertensive Therapy [ Time Frame: Baseline up to week 52 or early termination ] [ Designated as safety issue: No ]
    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".


Enrollment: 329
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
quinapril
quinapril
Drug: quinapril
per label as non interventional study
Other Name: Acupil®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930722

Locations
India
Pfizer Investigational Site
Patna, Bihar, India, 01
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 003
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 051
Pfizer Investigational Site
Ahmedabad, Maharashtra, India, 380 015
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440 033
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440 015
Pfizer Investigational Site
Pune, Maharashtra, India, 411 004
Pfizer Investigational Site
Delhi, New Delhi, India, 110017
Pfizer Investigational Site
Jaipur, Rajasthan, India, 302 020
Pfizer Investigational Site
Madurai, Tamil Nadu, India, 625003
Pfizer Investigational Site
Madurai, Tamil Nadu, India, 625014
Pfizer Investigational Site
Trichy, Tamil nadu, India, 620 021
Pfizer Investigational Site
Chennai, Tamilnadu, India, 600 035
Pfizer Investigational Site
Madurai, Tamilnadu, India, 625 107
Pfizer Investigational Site
Madurai, Tamilnadu, India, 625 010
Pfizer Investigational Site
Kanpur, UttarPradesh, India, 208005
Pfizer Investigational Site
Kolkata, West Bengal, India, 20
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00930722     History of Changes
Other Study ID Numbers: A9061066
Study First Received: June 29, 2009
Results First Received: April 7, 2011
Last Updated: April 7, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Pfizer:
Quinapril non-interventional/observational study safety

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Quinapril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014