Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00666198
First received: April 22, 2008
Last updated: August 3, 2015
Last verified: August 2015
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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 |
|---|---|
|
Pulmonary Hypertension |
Drug: SILDENAFIL |
| 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) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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 ]
| Enrollment: | 3337 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (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| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).
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).
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666198
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666198
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00666198 History of Changes |
| Other Study ID Numbers: | A1481263 |
| Study First Received: | April 22, 2008 |
| Last Updated: | August 3, 2015 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Sildenafil Citrate Vasodilator Agents |
Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |
ClinicalTrials.gov processed this record on September 23, 2016