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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00930722
First received: June 29, 2009
Last updated: April 7, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension |
Drug: quinapril |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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".
| Enrollment: | 329 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
quinapril
quinapril
|
Drug: quinapril
per label as non interventional study
Other Name: Acupil®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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®
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930722
Locations
| India | |
| Pfizer Investigational Site | |
| Patna, Bihar, India, 01 | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380 015 | |
| Pfizer Investigational Site | |
| Bangalore, Karnataka, India, 560 003 | |
| Pfizer Investigational Site | |
| Bangalore, Karnataka, India, 560 051 | |
| Pfizer Investigational Site | |
| Ahmedabad, Maharashtra, India, 380 015 | |
| Pfizer Investigational Site | |
| Nagpur, Maharashtra, India, 440 033 | |
| Pfizer Investigational Site | |
| Nagpur, Maharashtra, India, 440 015 | |
| Pfizer Investigational Site | |
| Pune, Maharashtra, India, 411 004 | |
| Pfizer Investigational Site | |
| Delhi, New Delhi, India, 110017 | |
| Pfizer Investigational Site | |
| Jaipur, Rajasthan, India, 302 020 | |
| Pfizer Investigational Site | |
| Madurai, Tamil Nadu, India, 625003 | |
| Pfizer Investigational Site | |
| Madurai, Tamil Nadu, India, 625014 | |
| Pfizer Investigational Site | |
| Trichy, Tamil nadu, India, 620 021 | |
| Pfizer Investigational Site | |
| Chennai, Tamilnadu, India, 600 035 | |
| Pfizer Investigational Site | |
| Madurai, Tamilnadu, India, 625 107 | |
| Pfizer Investigational Site | |
| Madurai, Tamilnadu, India, 625 010 | |
| Pfizer Investigational Site | |
| Kanpur, UttarPradesh, India, 208005 | |
| Pfizer Investigational Site | |
| Kolkata, West Bengal, India, 20 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00930722 History of Changes |
| Other Study ID Numbers: | A9061066 |
| Study First Received: | June 29, 2009 |
| Results First Received: | April 7, 2011 |
| Last Updated: | April 7, 2011 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Pfizer:
|
Quinapril non-interventional/observational study safety |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Quinapril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013