Trial Outcomes & Findings for A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population (NCT NCT00930722)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

329 participants

Primary outcome timeframe

Baseline to Week 52

Results posted on

2011-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Quinapril Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Overall Study STARTED	329
Overall Study COMPLETED	302
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Quinapril Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Overall Study Lost to Follow-up	16
Overall Study No longer willing to participate	9
Overall Study Study terminated by sponsor	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Age Continuous	52.5 Years STANDARD_DEVIATION 10.7 • n=93 Participants
Sex: Female, Male Female	145 Participants n=93 Participants
Sex: Female, Male Male	184 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to Week 52

Population: Full analysis set (FAS) included participants who received at least 1 dose of study medication including those who took it before enrollment.

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.

Outcome measures

Outcome measures
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse events	1 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious adverse events	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by last-observation-carried forward (LOCF).

Value at week 12 minus value at baseline.

Outcome measures

Outcome measures
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 Baseline	142.16 Millimeters of mercury (mmHg) Standard Deviation 12.93
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 Change at Week 12	-9.40 Millimeters of mercury (mmHg) Standard Deviation 11.18

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by LOCF.

Value at week 12 minus value at baseline.

Outcome measures

Outcome measures
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 Baseline	86.31 mmHg Standard Deviation 6.71
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 Change at Week 12	-3.93 mmHg Standard Deviation 6.29

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The "full analysis set - follow up" (FAS-FU) included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.

Value at week 52 minus value at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.

Value at week 52 minus value at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-treatment and Week 0

Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.

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.

Outcome measures

Outcome measures
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Change From Pre-treatment in SBP at Week 0 Change at Week 0	-12.49 mmHg Standard Deviation 11.69
Change From Pre-treatment in SBP at Week 0 Pre-treatment	154.06 mmHg Standard Deviation 13.50

SECONDARY outcome

Timeframe: Pre-treatment and Week 0

Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.

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.

Outcome measures

Outcome measures
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Change From Pre-treatment in DBP at Week 0 Pre-treatment	92.82 mmHg Standard Deviation 7.91
Change From Pre-treatment in DBP at Week 0 Change at Week 0	-6.74 mmHg Standard Deviation 8.20

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Subgroup analysis was performed for each subgroup of participants in the FAS defined by DM or renal disease status. Missing values were imputed by LOCF.

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.

Outcome measures

Outcome measures
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Number of Participants Achieving BP Goal at Week 12	78 Participants

SECONDARY outcome

Timeframe: Week 52

Population: The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to week 52 or early termination

Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed. Due to limited number of participants available, the analysis could not be performed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to week 52 or early termination

Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Mean Daily Dose of Study Medication	11.28 mg Standard Deviation 3.06

SECONDARY outcome

Timeframe: Baseline up to week 52 or early termination

Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.

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".

Outcome measures

Outcome measures
Measure	Quinapril n=329 Participants Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Number of Participants With Preference for add-on Anti-hypertensive Therapy None	321 Participants
Number of Participants With Preference for add-on Anti-hypertensive Therapy Metoprolol	1 Participants
Number of Participants With Preference for add-on Anti-hypertensive Therapy Metoprolol Succinate	1 Participants

Adverse Events

Quinapril

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Quinapril n=329 participants at risk Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
Gastrointestinal disorders Abdominal pain	0.30% 1/329 • Number of events 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER