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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00930722
First received: June 29, 2009
Last updated: April 7, 2011
Last verified: April 2011
Results First Received: April 7, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypertension
Intervention: Drug: quinapril

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Quinapril Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.

Participant Flow:   Overall Study
    Quinapril  
STARTED     329  
COMPLETED     302  
NOT COMPLETED     27  
Lost to Follow-up                 16  
No longer willing to participate                 9  
Study terminated by sponsor                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Quinapril Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.

Baseline Measures
    Quinapril  
Number of Participants  
[units: participants]
  329  
Age  
[units: Years]
Mean ± Standard Deviation
  52.5  ± 10.7  
Gender  
[units: Participants]
 
Female     145  
Male     184  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline to Week 52 ]

2.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) at Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Change From Baseline in SBP at Week 52   [ Time Frame: Baseline and Week 52 ]

5.  Secondary:   Change From Baseline in DBP at Week 52   [ Time Frame: Baseline and Week 52 ]

6.  Secondary:   Change From Pre-treatment in SBP at Week 0   [ Time Frame: Pre-treatment and Week 0 ]

7.  Secondary:   Change From Pre-treatment in DBP at Week 0   [ Time Frame: Pre-treatment and Week 0 ]

8.  Secondary:   Number of Participants Achieving BP Goal at Week 12   [ Time Frame: Week 12 ]

9.  Secondary:   Number of Participants With Achievement of BP Goal at Week 52   [ Time Frame: Week 52 ]

10.  Secondary:   Duration of Monotherapy With Quinapril   [ Time Frame: Baseline up to week 52 or early termination ]

11.  Secondary:   Mean Daily Dose of Study Medication   [ Time Frame: Baseline up to week 52 or early termination ]

12.  Secondary:   Number of Participants With Preference for add-on Anti-hypertensive Therapy   [ Time Frame: Baseline up to week 52 or early termination ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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