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

June 29, 2009
April 7, 2011
June 2009
June 2010   (final data collection date for primary outcome measure)
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.
Adverse events (including retrospective data) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00930722 on ClinicalTrials.gov Archive Site
  • 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".
  • The change of SBP & DBP from Week 0 at Week 12 (Interim Analysis on Week 12 cohort) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The change of SBP & DBP from Week 0 at Week 52 (Final Analysis) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • The change of SBP & DBP at Week 0 (Analysis from retrospective data) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The status of achieving BP goal at Week 12 (Interim Analysis on Week 12 cohort) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The status of achieving BP goal at Week 52 (End of Study) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Duration of monotherapy with Acupil® [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean daily dose of Acupil used in the study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Preference of add-on antihypertensive therapy [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Hypertension
Drug: quinapril
per label as non interventional study
Other Name: Acupil®
quinapril
quinapril
Intervention: Drug: quinapril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
329
June 2010
June 2010   (final data collection date for primary outcome measure)

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®
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00930722
A9061066
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP