Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00666198
First received: April 22, 2008
Last updated: October 6, 2014
Last verified: October 2014

April 22, 2008
October 6, 2014
May 2008
April 2018   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00666198 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).

Pulmonary Hypertension
Drug: SILDENAFIL

Revatio® Tablets 20 mg Dosage, Frequency: According to Japanese LPD, "For oral use, the adult dose is 20 mg three times a day".

Duration: According to the protocol of A1481263, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 3 years after the first administration.

SILDENAFIL
Patients taking SILDENAFIL.
Intervention: Drug: SILDENAFIL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
3100
April 2018
April 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered SILDENAFIL(Revatio).
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00666198
A1481263
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

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