N/A
N=3,337
Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00666198 ↗Enrolled (actual)
3,337
Serious AEs
29.7%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events — 448; 101 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SILDENAFIL (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
448; 101 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert |
196 | — |
| PRIMARY Number of Paritcipants With Treatment-Related Adverse Events by Age |
57; 391 | — |
| PRIMARY Number of Paritcipants With Treatment-Related Adverse Events by Gender |
323; 125 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events by Disease Type |
116; 136; 66; 4; 3; 25 | — |
| PRIMARY Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity |
34; 127; 204; 63; 20 | — |
| PRIMARY Clinical Efficacy Rate by Age |
72.0; 62.0 | — |
| PRIMARY Clinical Efficacy Rate by Gender |
65.9; 64.0 | — |
| PRIMARY Clinical Efficacy Rate by Disease Type |
67.6; 61.6; 72.9; 40.9; 55.9; 67.6 | — |
| PRIMARY Clinical Efficacy Rate by WHO Functional Classificaton of Severity |
76.2; 70.5; 64.2; 52.4; 57.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.
Exclusion Criteria
- Patients not administered SILDENAFIL(Revatio).
Data sourced from ClinicalTrials.gov (NCT00666198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.