Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (ESSENCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00749775
First received: September 5, 2008
Last updated: November 20, 2013
Last verified: November 2013
Results First Received: November 20, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypertension
Intervention: Drug: Selara

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Selara Participants taking Selara according to Japanese Package Insert.

Participant Flow:   Overall Study
    Selara  
STARTED     3317  
COMPLETED     3210  
NOT COMPLETED     107  
Protocol Violation                 24  
Lost to Follow-up                 36  
No visit after first day of treatment                 44  
No drug administration                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Selara Participants taking Selara according to Japanese Package Insert.

Baseline Measures
    Selara  
Number of Participants  
[units: participants]
  3210  
Age, Customized  
[units: participants]
 
<65 years old     1224  
>=65 years old     1986  
Gender  
[units: participants]
 
Female     1539  
Male     1671  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment Related Adverse Events.   [ Time Frame: 12 weeks ]

2.  Primary:   Number of Participants With Serious Treatment Related Adverse Events.   [ Time Frame: 12 weeks ]

3.  Secondary:   Change in Systolic Blood Pressure Over Time.   [ Time Frame: 12 weeks ]

4.  Secondary:   Change in Diastolic Blood Pressure Over Time.   [ Time Frame: 12 weeks ]

5.  Secondary:   Number of Participants That Responded to Selara Treatment.   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


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: Pfizer
ClinicalTrials.gov Identifier: NCT00749775     History of Changes
Other Study ID Numbers: A6141113
Study First Received: September 5, 2008
Results First Received: November 20, 2013
Last Updated: November 20, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency