HypertensionASSETNCT00930722
A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population
An observational study of Hypertension, run by Pfizer at 18 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- quinapril
- How many people
- 329 participants
- Where
- 18 sitesIndia
- Study dates
- Jun 2009to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients already on therapy with Acupil® for a minimum period of 4 weeks, Evidence of a personally signed and dated informed consent document
Who cannot join
- 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®
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
India18 sites
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 015
Pfizer Investigational Site
Ahmedabad, Maharashtra, 380 015
Pfizer Investigational Site
Bangalore, Karnataka, 560 003
Pfizer Investigational Site
Bangalore, Karnataka, 560 051
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 035
Pfizer Investigational Site
Delhi, New Delhi, 110017
Pfizer Investigational Site
Jaipur, Rajasthan, 302 020
Pfizer Investigational Site
Kanpur, Uttar Pradesh, 208005
Pfizer Investigational Site
Kolkata, West Bengal, 20
Pfizer Investigational Site
Madurai, Tamil Nadu, 625 010
Pfizer Investigational Site
Madurai, Tamil Nadu, 625 107
Pfizer Investigational Site
Madurai, Tamil Nadu, 625003
Pfizer Investigational Site
Madurai, Tamil Nadu, 625014
Pfizer Investigational Site
Nagpur, Maharashtra, 440 015
Pfizer Investigational Site
Nagpur, Maharashtra, 440 033
Pfizer Investigational Site
Patna, Bihar, 01
Pfizer Investigational Site
Pune, Maharashtra, 411 004
Pfizer Investigational Site
Trichy, Tamil Nadu, 620 021
About this study
Official title: ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)
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.
- Conditions
- Hypertension
- Being tested
- quinapril
- Keywords
- Quinapril non-interventional/observational study safety
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quinaprilDrug
Also called Acupil®
per label as non interventional study
| Study group | Role | What they receive |
|---|---|---|
| quinapril | quinapril Receives: Drug: quinapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 52
Secondary outcomes (11)
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
Value at week 12 minus value at baseline.
Measured: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
Value at week 12 minus value at baseline.
Measured: Baseline and Week 12
Change From Baseline in SBP at Week 52
Value at week 52 minus value at baseline.
Measured: Baseline and Week 52
Change From Baseline in DBP at Week 52
Value at week 52 minus value at baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 52
Duration of Monotherapy With Quinapril
Time in weeks to the first "taking additional antihypertensive medication" since Quinapril therapy began.
Measured: 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.
Measured: 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".
Measured: Baseline up to week 52 or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930722
- Sponsor's protocol ID
- A9061066
- Acronym
- ASSET
- Status last verified
- Apr 2011
- First submitted
- 29 Jun 2009
- Last updated
- 4 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)
- ClinicalTrials.gov ID
- NCT00930722
- Acronym / sponsor ID
- ASSET / A9061066
- Conditions
- Hypertension
- Keywords
- Quinapril non-interventional/observational study safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Posted 4 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quinapril | – | Drug: quinaprilquinapril |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients already on therapy with Acupil® for a minimum period of 4 weeks, Evidence of a personally signed and dated informed consent document
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quinaprilAlso: Acupil®per label as non interventional study | Drug | quinapril |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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.
11 secondary outcomes
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in SBP at Week 52
Time frame: Baseline and Week 52
Change From Baseline in DBP at Week 52
Time frame: Baseline and Week 52
Change From Pre-treatment in SBP at Week 0
Time frame: Pre-treatment and Week 0
Change From Pre-treatment in DBP at Week 0
Time frame: Pre-treatment and Week 0
Number of Participants Achieving BP Goal at Week 12
Time frame: Week 12
Number of Participants With Achievement of BP Goal at Week 52
Time frame: Week 52
Duration of Monotherapy With Quinapril
Time frame: Baseline up to week 52 or early termination
Mean Daily Dose of Study Medication
Time frame: Baseline up to week 52 or early termination
Number of Participants With Preference for add-on Anti-hypertensive Therapy
Time frame: Baseline up to week 52 or early termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Pfizer at 18 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2011.