Pulmonary HypertensionNCT00666198
Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
An observational study of Pulmonary Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- SILDENAFIL
- Type of treatment
- Pill or oral medicine
- How many people
- 3,337 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).
Who may be able to join
- Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.
Who cannot join
- Patients not administered SILDENAFIL(Revatio).
About this study
Official title: Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan)
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.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- SILDENAFIL
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILDENAFILDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SILDENAFIL | Patients taking SILDENAFIL. Receives: Drug: SILDENAFIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666198
- Sponsor's protocol ID
- A1481263
- Status last verified
- Jan 2021
- First submitted
- 22 Apr 2008
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan)
- ClinicalTrials.gov ID
- NCT00666198
- Acronym / sponsor ID
- A1481263
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,337 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SILDENAFIL | – | Drug: SILDENAFILPatients taking SILDENAFIL. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).
Key inclusion criteria (1 listed)
- Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.
Key exclusion criteria (1 listed)
- Patients not administered SILDENAFIL(Revatio).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SILDENAFILRevatio® 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. | Drug | SILDENAFIL |
Primary outcome
Number of Participants With Treatment-Related Adverse Events
Time frame: 3 years
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.
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Time frame: 3 years
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.
Number of Paritcipants With Treatment-Related Adverse Events by Age
Time frame: 3 years
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.
Number of Paritcipants With Treatment-Related Adverse Events by Gender
Time frame: 3 years
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.
Number of Participants With Treatment-Related Adverse Events by Disease Type
Time frame: 3 years
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".
Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity
Time frame: 3 years
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.
Clinical Efficacy Rate by Age
Time frame: 3 years
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.
Clinical Efficacy Rate by Gender
Time frame: 3 years
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.
Clinical Efficacy Rate by Disease Type
Time frame: 3 years
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".
Clinical Efficacy Rate by WHO Functional Classificaton of Severity
Time frame: 3 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events (time frame: 3 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.