A Non Interventional Study To Asses The Safety, Effectiveness And Tolerability Of Quinapril (Acupil®) In An Indian Population
NCT00930722
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- Patients already on therapy with Acupil® for a minimum period of 4 weeks, Evidence of a personally signed and dated informed consent document
- 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®
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | 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) | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| 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. | |||
| Condition | Hypertension | |||
| Intervention | Drug: quinapril
per label as non interventional study Other Name: Acupil® | |||
| Study Groups/Cohorts | quinapril
quinapril Intervention: Drug: quinapril | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 329 | |||
| Original Estimated Enrollment | 400 | |||
| Actual Study Completion Date | June 2010 | |||
| Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | India | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00930722 | |||
| Other Study ID Numbers | A9061066 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2011 | |||