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

Completed

Conditions: Hypertension

Interventions: Drug: quinapril

Registration Number: NCT00930722

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 329

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
quinapril	quinapril	quinapril

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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 Outcome Measures

Name	Time	Method
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12	Baseline and Week 12	Value at week 12 minus value at baseline.
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12	Baseline and Week 12	Value at week 12 minus value at baseline.
Change From Baseline in SBP at Week 52	Baseline and Week 52	Value at week 52 minus value at baseline.
Change From Baseline in DBP at Week 52	Baseline and Week 52	Value at week 52 minus value at baseline.
Change From Pre-treatment in SBP at Week 0	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.
Change From Pre-treatment in DBP at Week 0	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.
Number of Participants Achieving BP Goal at Week 12	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.
Number of Participants With Achievement of BP Goal at Week 52	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.
Duration of Monotherapy With Quinapril	Baseline up to week 52 or early termination	Time in weeks to the first "taking additional antihypertensive medication" since Quinapril therapy began.
Mean Daily Dose of Study Medication	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.
Number of Participants With Preference for add-on Anti-hypertensive Therapy	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".