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

• ClinicalTrials.gov Identifier: NCT00930722
• Recruitment Status: Completed
• First Posted: June 30, 2009
• Results First Posted: May 4, 2011
• Last Update Posted: May 4, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

Brief 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. 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 or disease	Intervention/treatment
Hypertension	Drug: quinapril

Study Design

• Study Type: Observational
• Actual Enrollment: 329 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)
• Study Start Date: June 2009
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: June 2010

Groups and Cohorts

Group/Cohort	Intervention/treatment
quinapril; quinapril	Drug: quinapril; per label as non interventional study; Other Name: Acupil®

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 [ Time Frame: Baseline and Week 12 ]
   Value at week 12 minus value at baseline.
2. Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 [ Time Frame: Baseline and Week 12 ]
   Value at week 12 minus value at baseline.
3. Change From Baseline in SBP at Week 52 [ Time Frame: Baseline and Week 52 ]
   Value at week 52 minus value at baseline.
4. Change From Baseline in DBP at Week 52 [ Time Frame: Baseline and Week 52 ]
   Value at week 52 minus value at baseline.
5. Change From Pre-treatment in SBP at Week 0 [ Time Frame: Pre-treatment and 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.
6. Change From Pre-treatment in DBP at Week 0 [ Time Frame: Pre-treatment and 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.
7. Number of Participants Achieving BP Goal at Week 12 [ Time Frame: 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.
8. Number of Participants With Achievement of BP Goal at Week 52 [ Time Frame: 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.
9. Duration of Monotherapy With Quinapril [ Time Frame: Baseline up to week 52 or early termination ]
   Time in weeks to the first "taking additional antihypertensive medication" since Quinapril therapy began.
10. Mean Daily Dose of Study Medication [ Time Frame: Baseline up to week 52 or early termination ]
    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.
11. Number of Participants With Preference for add-on Anti-hypertensive Therapy [ Time Frame: Baseline up to week 52 or early termination ]
    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".

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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, 440 015

Pfizer Investigational Site

Nagpur, Maharashtra, India, 440 033

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, 625 010

Pfizer Investigational Site

Madurai, Tamilnadu, India, 625 107

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:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• ClinicalTrials.gov Identifier: NCT00930722
• Other Study ID Numbers: A9061066
• First Posted: June 30, 2009
• Results First Posted: May 4, 2011
• Last Update Posted: May 4, 2011
• Last Verified: April 2011

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; Antihypertensive Agents