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

NCT00666198 | Completed Results

• 1 other identifier: A1481263
• Study Type: observational
• Target: 3,337
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (10)

• Number of Participants With Treatment-Related Adverse Events

  A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sildenafil citrate was assessed by the physician/investigator.

  3 years

• Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

  A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sildenafil citrate was assessed by the physician/investigator.

  3 years

• Number of Paritcipants With Treatment-Related Adverse Events by Age

  A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether it was risk factor for the treatment related adverse events.

  3 years

• Number of Paritcipants With Treatment-Related Adverse Events by Gender

  A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether it was risk factor for the treatment related adverse events.

  3 years

• Number of Participants With Treatment-Related Adverse Events by Disease Type

  A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by disease type to assess whether it was risk factor for the treatment related adverse events. \* indicates "Associated Pulmonary Arterial Hypertension (APAH)". \*\* refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis".

  3 years

• Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity

  A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by severity (WHO functional classification for PAH range;This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH) to assess whether it was risk factor for the treatment related adverse events.

  3 years

• Clinical Efficacy Rate by Age

  Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness.

  3 years

• Clinical Efficacy Rate by Gender

  Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness.

  3 years

• Clinical Efficacy Rate by Disease Type

  Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by disease type were counted to assess whether it contributes to the clinical effectiveness. \* indicates "Associated Pulmonary Arterial Hypertension (APAH)". \*\* refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis".

  3 years

• Clinical Efficacy Rate by WHO Functional Classificaton of Severity

  Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by severity (WHO functional classification of PAH;The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links) were counted to assess whether it contributes to the clinical effectiveness.

  3 years

Study Arms (1)

SILDENAFIL

Patients taking SILDENAFIL.

Drug: SILDENAFIL

Interventions

SILDENAFIL DRUG

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

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients not administered SILDENAFIL(Revatio).

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 1, 2021
• Results First Posted: April 24, 2017

Record last verified: 2021-01