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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: quinapril


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| quinapril<br>quinapril | Drug: quinapril<br>* per label as non interventional study<br>* Other names: Acupil®;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quinapril non-interventional/observational study safety