Pulmonary Arterial HypertensionNCT01365585
Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in 2 countries.
Trial summary
The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- sildenafil citrate
- Type of treatment
- Pill or oral medicine
- How many people
- 227 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2011to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH
Who may be able to join
- Patients must be at least 18 years of age at study index;
- Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization;
- Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation
Who cannot join
- Patient has known contraindications to sildenafil at study index;
- Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.
Read the detailed description
The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- sildenafil citrate
- Keywords
- Pulmonary arterial hypertension, sildenafil citrate, Revatio
- 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.
sildenafil citrateDrug
Sildenafil citrate, 20mg oral tablets, taken at least three times daily
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil ≥20mg three times daily | Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH Receives: Drug: sildenafil citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Measured: Baseline, Year 1
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Measured: Baseline, Year 2
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Measured: Baseline, Year 3
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Measured: Baseline, Year 4
Secondary outcomes (7)
Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4
NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.
Measured: Baseline, Year 1, 2, 3, 4
Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4
RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
Measured: Baseline, Year 1, 2, 3, 4
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4
mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
Measured: Baseline, Year 1, 2, 3, 4
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4
PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).
Measured: Baseline, Year 1, 2, 3, 4
Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4
CI: calculated as COsys divided by BSA.
Measured: Baseline, Year 1, 2, 3, 4
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4
PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.
Measured: Baseline, Year 1, 2, 3, 4
Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4
Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.
Measured: Baseline, Year 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
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 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 227 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
- NCT01365585
- Sponsor's protocol ID
- A1481297
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2011
- 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
- Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01365585
- Acronym / sponsor ID
- A1481297
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary arterial hypertension, sildenafil citrate, Revatio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Posted 31 Oct 2012
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 observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.
Detailed description
The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sildenafil ≥20mg three times daily | – | Drug: sildenafil citrateSubjects receiving sildenafil ≥20mg three times daily for the treatment of PAH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH
Key inclusion criteria (3 listed)
- Patients must be at least 18 years of age at study index;
- Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization;
- Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation
Key exclusion criteria (2 listed)
- Patient has known contraindications to sildenafil at study index;
- Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index
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 citrateSildenafil citrate, 20mg oral tablets, taken at least three times daily | Drug | Sildenafil ≥20mg three times daily |
Primary outcome
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1
Time frame: Baseline, Year 1
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2
Time frame: Baseline, Year 2
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3
Time frame: Baseline, Year 3
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4
Time frame: Baseline, Year 4
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
7 secondary outcomes
Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, 2, 3, 4
Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, 2, 3, 4
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, 2, 3, 4
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, 2, 3, 4
Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, 2, 3, 4
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, 2, 3, 4
Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, 2, 3, 4
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.
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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
2 sites in 2 countries: 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 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in 2 countries.
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 3 inclusion and 2 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.
Where is the study taking place?
The record lists 2 sites in Germany, Ireland. 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?
Yes. Results are posted in the registry (first posted 31 Oct 2012). 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?
Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1 (time frame: Baseline, Year 1). The study lists 4 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.