Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension |
Drug: SILDENAFIL |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan) |
- 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 ]
| Estimated Enrollment: | 3100 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | April 2018 |
| Estimated Primary Completion Date: | April 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
SILDENAFIL
Patients taking SILDENAFIL.
|
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. |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).
Inclusion Criteria:
- Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered SILDENAFIL(Revatio).
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00666198
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00666198 History of Changes |
| Other Study ID Numbers: | A1481263 |
| Study First Received: | April 22, 2008 |
| Last Updated: | December 30, 2014 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Vascular Diseases Sildenafil Cardiovascular Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Therapeutic Uses Urological Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on February 25, 2015