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Completed

NCT Number: NCT00930722

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Patna, Bihar, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Quinapril

Drug

per label as non interventional study

Other names: Acupil®

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline to Week 52

    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 outcomes

  1. Change From Baseline in Systolic Blood Pressure (SBP) at Week 12

    Time frame: Baseline and Week 12

    Value at week 12 minus value at baseline.

  2. Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12

    Time frame: Baseline and Week 12

    Value at week 12 minus value at baseline.

  3. Change From Baseline in SBP at Week 52

    Time frame: Baseline and Week 52

    Value at week 52 minus value at baseline.

  4. Change From Baseline in DBP at Week 52

    Time frame: Baseline and Week 52

    Value at week 52 minus value at baseline.

  5. Change From Pre-treatment in SBP at Week 0

    Time frame: Pre-treatment and 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.

  6. Change From Pre-treatment in DBP at Week 0

    Time frame: Pre-treatment and 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.

  7. Number of Participants Achieving BP Goal at Week 12

    Time frame: 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.

  8. Number of Participants With Achievement of BP Goal at Week 52

    Time frame: 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.

  9. Duration of Monotherapy With Quinapril

    Time frame: Baseline up to week 52 or early termination

    Time in weeks to the first "taking additional antihypertensive medication" since Quinapril therapy began.

  10. Mean Daily Dose of Study Medication

    Time frame: Baseline up to week 52 or early termination

    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.

  11. Number of Participants With Preference for add-on Anti-hypertensive Therapy

    Time frame: Baseline up to week 52 or early termination

    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".

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)

Acronym: ASSET

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2009
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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