An observational study in Hypertension, sponsored by Pfizer. Completed at 18 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-04.
Sponsored by Pfizer · Observational
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 329 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
quinapril
Drug: quinapril
per label as non interventional study
Also known as: Acupil®
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.
Time frame: Baseline to Week 52
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
Value at week 12 minus value at baseline.
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
Value at week 12 minus value at baseline.
Time frame: Baseline and Week 12
Change From Baseline in SBP at Week 52
Value at week 52 minus value at baseline.
Time frame: Baseline and Week 52
Change From Baseline in DBP at Week 52
Value at week 52 minus value at baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 52
Duration of Monotherapy With Quinapril
Time in weeks to the first "taking additional antihypertensive medication" since Quinapril therapy began.
Time frame: 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.
Time frame: 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".
Time frame: Baseline up to week 52 or early termination
| Milestone | Quinapril |
|---|---|
| Started | 329 |
| Completed | 302 |
| Not completed | 27 |
| Withdrew: Lost to follow-up | 16 |
| Withdrew: No longer willing to participate | 9 |
| Withdrew: Study terminated by sponsor | 2 |
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.
| Participants | Quinapril |
|---|---|
| Adverse events | 1 |
| Serious adverse events | 0 |
Value at week 12 minus value at baseline.
| Millimeters of mercury (mmHg) | Quinapril |
|---|---|
| Baseline | 142.16 ± 12.93 |
| Change at Week 12 | -9.40 ± 11.18 |
Value at week 12 minus value at baseline.
| mmHg | Quinapril |
|---|---|
| Baseline | 86.31 ± 6.71 |
| Change at Week 12 | -3.93 ± 6.29 |
Value at week 52 minus value at baseline.
No measurements were reported for this outcome.
Value at week 52 minus value at baseline.
No measurements were reported for this outcome.
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.
| mmHg | Quinapril |
|---|---|
| Pre-treatment | 154.06 ± 13.50 |
| Change at Week 0 | -12.49 ± 11.69 |
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.
| mmHg | Quinapril |
|---|---|
| Pre-treatment | 92.82 ± 7.91 |
| Change at Week 0 | -6.74 ± 8.20 |
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.
| Participants | Quinapril |
|---|---|
| Number of Participants Achieving BP Goal at Week 12 | 78 |
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.
No measurements were reported for this outcome.
Time in weeks to the first "taking additional antihypertensive medication" since Quinapril therapy began.
No measurements were reported for this outcome.
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.
| mg | Quinapril |
|---|---|
| Mean Daily Dose of Study Medication | 11.28 ± 3.06 |
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".
| Participants | Quinapril |
|---|---|
| None | 321 |
| Metoprolol | 1 |
| Metoprolol Succinate | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quinapril | — | 0/329 (0%) | 1/329 (0.3%) |
| Event | Quinapril |
|---|---|
| Abdominal painGastrointestinal disorders | 1/329 |
| Age Continuous(Years) | Quinapril |
|---|---|
| Mean | 52.5 ± 10.7 |
| Sex: Female, Male(Participants) | Quinapril |
|---|---|
| Female | 145 |
| Male | 184 |
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer