Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan) - Tabular View

Tracking Information

First Received Date ^ICMJE

April 22, 2008

Last Updated Date

November 4, 2008

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The incidence of adverse drug reactions in this surveillance. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00666198 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

This surveillance is a non-interventional/observational surveillance and dose not have any secondary outcomes. [ Time Frame: There is no secondary outcomes for this surveillance. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)

Official Title ^ICMJE

Special Investigation For Long-Term Use Of Revatio (Regulatory Post Marketing Commitment Plan)

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed Description

All the patients whom an investigator prescribes the first SILDENAFIL(Revatio) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Phase

Phase IV

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Pulmonary Hypertension

Intervention ^ICMJE

Drug: SILDENAFIL

Study Arms / Comparison Groups

Patients taking SILDENAFIL.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

2000

Estimated Completion Date

March 2016

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

-Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.

Exclusion Criteria:

-Patients not administered SILDENAFIL(Revatio).

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00666198

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A1481263

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP