Pulmonary Arterial HypertensionNCT03364244
Revatio Special Investigation for Long-term Use in Pediatric Patients
An observational study of Pulmonary Arterial Hypertension, run by Viatris Pharmaceuticals Japan Inc at 1 site in Japan.
Trial summary
Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice Read more about this study
- Who is it for?
- Ages 0 to 14 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- How many people
- 1,023 participants
- Where
- 1 siteJapan
- Study dates
- 30 Nov 2017to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio after the approval date of dosage and administration of Revatio for pediatric patients
Who may be able to join
- Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio after the approval date of dosage and administration of Revatio for pediatric patients.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Viatris Pharmaceuticals Japan Inc., 5-11-2; Toranomon, Minato-ku
Tokyo
About this study
Official title: Revatio Special Investigation - Investigation for Long-Term Use of Revatio in Pediatric Patients
Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice
Read the detailed description
The objective of this study is to obtain the information on dosage and administration, safety, and efficacy of Revatio when it is administered for a long period of time (1 year) under the actual use after the approval of the dosage and administration in pediatric patients (aged 1 year or older, weighed 8 kg or more) .
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sildenafil
- Keywords
- Revatio, Pulmonary arterial hypertension, Pediatric patients
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
[REVATIO® Tablets / REVATIO® OD Film] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily.
[REVATIO® Dry Syrup for Suspension] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 8 kg or more but less than 20 kg: Usually, sildenafil 10 mg is orally given three times daily.
In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Pediatric patients receiving Revatio Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions
The number of cases of adverse drug reactions during the observation period and their ratio are tabulated for each SOC and PT.
Measured: 1 year (52 week) after observation start date
Effictiveness rate for physician's evaluation of this product
For the judgment of clinical effect at each evaluation time point (16th week, 52nd week and final evaluation time), the frequency (number of cases) and the ratio of each classification (valid, invalid, undecidable) are calculated.
Measured: 1 year (52 week) after observation start date
Secondary outcomes (1)
the dosage and administration under the actual use (including patients under the age of 1 year, weighing below 8 kg)
The mean doses at the initial , 16th, 52nd, and final evaluations are summarized for each newly treated case since dosage approval and continued case before dosage approval.
Measured: 1 year (52 week) after observation start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start30 Nov 2017
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial 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
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Pharmaceuticals Japan Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajesh Nachankar, Study director, Viatris Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364244
- Sponsor's protocol ID
- A1481319
- Status last verified
- Sep 2022
- First submitted
- 30 Nov 2017
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sponsor will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revatio Special Investigation - Investigation for Long-Term Use of Revatio in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03364244
- Acronym / sponsor ID
- A1481319
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Revatio, Pulmonary arterial hypertension, Pediatric patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Viatris Pharmaceuticals Japan IncIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice
Detailed description
The objective of this study is to obtain the information on dosage and administration, safety, and efficacy of Revatio when it is administered for a long period of time (1 year) under the actual use after the approval of the dosage and administration in pediatric patients (aged 1 year or older, weighed 8 kg or more) .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | – | Drug: SildenafilPediatric patients receiving Revatio |
Who may qualify
- Ages
- 0 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio after the approval date of dosage and administration of Revatio for pediatric patients
Key inclusion criteria (1 listed)
- Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio after the approval date of dosage and administration of Revatio for pediatric patients.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Sildenafil[REVATIO® Tablets / REVATIO® OD Film] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily. [REVATIO® Dry Syrup for Suspension] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 8 kg or more but less than 20 kg: Usually, sildenafil 10 mg is orally given three times daily. In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily. | Drug | Sildenafil |
Primary outcome
Incidence of adverse drug reactions
Time frame: 1 year (52 week) after observation start date
The number of cases of adverse drug reactions during the observation period and their ratio are tabulated for each SOC and PT.
Effictiveness rate for physician's evaluation of this product
Time frame: 1 year (52 week) after observation start date
For the judgment of clinical effect at each evaluation time point (16th week, 52nd week and final evaluation time), the frequency (number of cases) and the ratio of each classification (valid, invalid, undecidable) are calculated.
1 secondary outcome
the dosage and administration under the actual use (including patients under the age of 1 year, weighing below 8 kg)
Time frame: 1 year (52 week) after observation start date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Sponsor will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
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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.
Rajesh Nachankar study director
Viatris Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Viatris Pharmaceuticals Japan Inc at 1 site in Japan.
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 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse drug reactions (time frame: 1 year (52 week) after observation start date). The study lists 2 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 3 Oct 2022.