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

History of Changes

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

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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
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

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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
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

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1. Primary:

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

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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

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

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