Clinical trial NCT00930722: A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population
Official title: ASSET (Acupil® Non Interventional Study For Evaluation Of Safety Effectiveness And Tolerability)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Quinapril non-interventional/observational study safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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®

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in SBP at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in DBP at Week 52
timeFrame: Baseline and Week 52
measure: Change From Pre-treatment in SBP at Week 0
timeFrame: Pre-treatment and Week 0
measure: Change From Pre-treatment in DBP at Week 0
timeFrame: Pre-treatment and Week 0
measure: Number of Participants Achieving BP Goal at Week 12
timeFrame: Week 12
measure: Number of Participants With Achievement of BP Goal at Week 52
timeFrame: Week 52
measure: Duration of Monotherapy With Quinapril
timeFrame: Baseline up to week 52 or early termination
measure: Mean Daily Dose of Study Medication
timeFrame: Baseline up to week 52 or early termination
measure: Number of Participants With Preference for add-on Anti-hypertensive Therapy
timeFrame: Baseline up to week 52 or early termination
Other outcomes:
Locations:
city: Patna
country: India
facility: Pfizer Investigational Site
state: Bihar
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Delhi
country: India
facility: Pfizer Investigational Site
state: New Delhi
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Madurai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Madurai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Trichy
country: India
facility: Pfizer Investigational Site
state: Tamil nadu
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamilnadu
city: Madurai
country: India
facility: Pfizer Investigational Site
state: Tamilnadu
city: Madurai
country: India
facility: Pfizer Investigational Site
state: Tamilnadu
city: Kanpur
country: India
facility: Pfizer Investigational Site
state: UttarPradesh
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: