Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
This study has been completed.
Information provided by (Responsible Party):
First received: April 22, 2008
Last updated: August 3, 2015
Last verified: August 2015
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan)
Primary Outcome Measures:
- 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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Patients taking 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.
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.
|Ages Eligible for Study:
||Child, Adult, Senior
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).
- Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.
- Patients not administered SILDENAFIL(Revatio).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00666198
||Pfizer CT.gov Call Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 22, 2008
||August 3, 2015
||Japan: Pharmaceuticals and Medical Devices Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
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