Pulmonary Arterial HypertensionPhase 4AFFILIATENCT02060487
Effects of Oral Sildenafil on Mortality in Adults With PAH
A Phase 4 study testing sildenafil citrate in people with Pulmonary Arterial Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 82 sites in 23 countries.
Trial summary
This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- sildenafil citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 82 sitesin 23 countries
- Study dates
- 22 Sep 2014to 26 Feb 2021
- Phase
- Phase 4
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥ 18 <75 years of age with any of the following conditions:
- Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
- PAH secondary to connective tissue disease
- PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
- PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
- Functional Class II-IV; Baseline 6MWD ≥ 50 m.
Who cannot join
- Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
- History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
- History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
- No prior long term treatment with PDE-5 inhibitors
- Treatment with bosentan OR riociguat within 3 months of randomization
- Current treatment with nitrates or nitric oxide
Trial locations and contacts
82 sites in 23 countries.
82 sites in 23 countries
United States11 sites
Emory University Investigational Drug Services
Atlanta, Georgia, 30322
The Emory Clinic
Atlanta, Georgia, 30322
UT Southwestern Medical School
Dallas, Texas, 75390-8550
Frederik Meijer Heart & Vascular Institute Cardiovascular Research
Grand Rapids, Michigan, 49503
Spectrum Health Butterworth Hospital IDS Pharmacy
Grand Rapids, Michigan, 49503
Spectrum Health Heart & Lung Specialized Care Clinic
Grand Rapids, Michigan, 49503
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Spectrum Health Medical Group - Pulmonary Division
Grand Rapids, Michigan, 49546
Spectrum Health
Grand Rapids, Michigan, 49546
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Robert V. Sibilia MD, Inc.
Wooster, Ohio, 44691
Germany7 sites
DRK Kliniken Berlin, Westend
Berlin, 14050
Universitaetsklinikum der TU Dresden
Dresden, 01307
Universitatsklinikum TU Dresden
Dresden, 01307
Universitaetsmedizin Greifswald
Greifswald, 17475
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Thoraxklinik am Universitaetsklinikum Heidelberg
Heidelberg, 69126
Universitaetsklinikum Schleswig-Holstein
Lübeck, 23538
Thailand7 sites
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, 50200
Division of Cardiology, Department of Medicine, Faculty of Medicine, Khon Kaen University
Muang District, Changwat Khon Kaen, 40002
Queen Sirikit Heart Center of the Northeast, Khon Kaen University
Muang District, Changwat Khon Kaen, 40002
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Muang District, Changwat Khon Kaen, 40002
Faculty of Medicine, Chulalongkorn University
Pathumwan, Bangkok, 10330
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
Pathumwan, Bangkok, 10330
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
Sripoom Sub-district, Muang, Chiang Mai, 50200
Ukraine6 sites
Komunalne nekomertsiine pidpryiemstvo
Kharkiv, 61176
Komunalne nekomertsiine pidpryiemstvo Oleksandrivska klinichna likarnia m. Kyieva
Kyiv, 01601
Komunalne nekomertsiine pidpryiemstvo
Kyiv, 03115
Derzhavna ustanova Natsionalnyi naukovyi tsentr
Kyiv, 03680
Komunalne pidpryiemstvo "Dnipropetrovskyi oblasnyi klinichnyi tsentr kardiolohii ta kardiokhirurhii"
M. Dnipro, 49044
Komunalne nekomertsiine pidpryiemstvo
Uzhhorod, 88000
Serbia5 sites
Clinical Center of Serbia
Belgrade, 11000
University Medical Center Zvezdara
Belgrade, 11000
Institute for Cardiovascular disease of Vojvodina
Kamenitz, Vojvodina, 21204
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, Vojvodina, 21204
Clinical Center Kragujevac
Kragujevac, 34 000
Turkey (Türkiye)5 sites
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Bakirkoy, 34147
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Fatih, 34096
Istanbul University Haseki Cardiology Institute
Istanbul, Fatih, 34096
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
Dokuz Eylul Üniversitesi Tıp Fakültesi Kardiyoloji Bilim Dalı
Izmir, Inciralti, 35340
Australia4 sites
Australian Respiratory and Sleep Medicine Institute
Bedford Park, South Australia, 5042
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029
Westmead Hospital
Westmead, New South Wales, 2145
Bosnia and Herzegovina4 sites
University Clinical Center of the Republic of Srpska
Banja Luka, B&h/republic of Srpska, 78000
University Clinical Hospital Mostar
Mostar, Herzegovina-neretva Canton, 88000
Clinical Center University Sarajevo
Sarajevo, Bosnia and Herzegovina/canton Sarajevo, 71000
Health Institution Special Hospital "Medical Institute Bayer"
Tuzla, Canton Tuzla, 75000
Greece4 sites
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
University General Hospital of Athens "Attikon"
Athens, Attica, 12462
University General Hospital of Patras
Pátrai, 26504
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636
Malaysia4 sites
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460
Hospital Sultanah Aminah
Johor Bahru, Johor, 80100
Hospital Serdang
Kajang, Selangor, 43000
University Malaya Medical Centre
Kuala Lumpur, 59100
Russia4 sites
FSBI "Research Institute of complex problems of cardiovascular diseases"
Kemerovo, 650002
FSBI Scientific Research Institute of Pulmonology of FMBA
Moscow, 105077
FSBI "E.Meshalkin National medical research center"
Novosibirsk, 630055
FSBI "V.A. Almazov National Medical Research Center"
Saint Petersburg, Russian Federation, 197341
Czechia3 sites
Fakultni nemocnice Olomouc
Olomouc, 779 00
Vseobecna fakultni nemocnice v Praze
Prague, Czech Republic, 128 08
Institut Klinicke a Experimentalni Mediciny
Prague, 140 21
Mexico3 sites
Centro de Desarrollo Biomedico
Mérida, Yucatán, 97070
Centro De Prevencion Y Rehabilitacion De Enfermedades Pulmonares Crónicas
Monterrey, Nuevo León, 64460
Centro de Estudios Clinicos de Queretaro S.C.
Querétaro, 76000
Croatia2 sites
University Hospital Center Zagreb
Zagreb, 10 000
University Hospital Dubrava
Zagreb, 10000
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin, New Territories
Romania2 sites
Institutul Inimii ,,Niculae Stancioiu" Cluj Napoca
Cluj-Napoca, 400001
Institutul de Urgenta pentru Boli Cardiovasculare si Transplant Targu-Mures
Târgu Mureş, 540136
Singapore2 sites
National University Heart Centre, National University Hospital Singapore (NUHS)
Singapore, 119228
Khoo Teck Puat Hospital
Singapore, 768828
South Africa2 sites
Center of Chest Diseases
Johannesburg, Gauteng, 2193
Dr PG Williams Practice
Johannesburg, Gauteng, 2193
About this study
Official title: A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- sildenafil citrate
- Keywords
- pulmonary arterial hypertension, pulmonary hypertension, PAH, sildenafil, revatio
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafil citrateDrug
Also called Revatio
sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study
sildenafil citrateDrug
Also called Revatio
sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study
sildenafil citrateDrug
Also called Revatio
sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: sildenafil citrate |
| Medium dose | Experimental | Not described Receives: Drug: sildenafil citrate |
| High dose | Experimental | Not described Receives: Drug: sildenafil citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
In this outcome measure number of deaths during the study were reported.
Measured: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)
Secondary outcomes (3)
Number of Participants With Clinical Worsening Events
Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure [RHF], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment.
Measured: Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days)
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6
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. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.
Measured: Baseline, Month 6
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12
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. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study start22 Sep 2014
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Why it stopped: Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met.
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 385 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
- NCT02060487
- Sponsor's protocol ID
- A1481324
- Other IDs
- 2013-004362-34, AFFILIATE
- Acronym
- AFFILIATE
- Status last verified
- May 2022
- First submitted
- 29 Jan 2014
- Last updated
- 13 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer 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. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Hoeper MM, Ewert R, Jansa P, Sirenko Y, Skride A, Balagtas C, Hackley S, Vogt S, Abreu P, Haughie S, Hassan T, Oudiz RJ. Randomized, Multicenter Study to Assess the Effects of Different Doses of Sildenafil on Mortality in Adults With Pulmonary Arterial Hypertension. Circulation. 2024 Jun 18;149(25):1949-1959. doi: 10.1161/CIRCULATIONAHA.123.068107. Epub 2024 May 16.
PubMed 38752352
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
- ClinicalTrials.gov ID
- NCT02060487
- Acronym / sponsor ID
- AFFILIATE / A1481324
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary arterial hypertension, pulmonary hypertension, PAH, sildenafil, revatio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met.
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2014 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: sildenafil citrate |
| Medium dose | Experimental | Drug: sildenafil citrate |
| High dose | Experimental | Drug: sildenafil citrate |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
- PAH secondary to connective tissue disease
- PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
- PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
- Functional Class II-IV; Baseline 6MWD ≥ 50 m.
Key exclusion criteria (6 listed)
- Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
- History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
- History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
- No prior long term treatment with PDE-5 inhibitors
- Treatment with bosentan OR riociguat within 3 months of randomization
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 citrateAlso: Revatiosildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study | Drug | Low dose |
| sildenafil citrateAlso: Revatiosildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study | Drug | Medium dose |
| sildenafil citrateAlso: Revatiosildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study | Drug | High dose |
Primary outcome
Overall Survival
Time frame: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)
In this outcome measure number of deaths during the study were reported.
3 secondary outcomes
Number of Participants With Clinical Worsening Events
Time frame: Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days)
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6
Time frame: Baseline, Month 6
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38752352Hoeper MM, Ewert R, Jansa P, Sirenko Y, Skride A, Balagtas C, Hackley S, Vogt S, Abreu P, Haughie S, Hassan T, Oudiz RJ. Randomized, Multicenter Study to Assess the Effects of Different Doses of Sildenafil on Mortality in Adults With Pulmonary Arterial Hypertension. Circulation. 2024 Jun 18;149(25):1949-1959. doi: 10.1161/CIRCULATIONAHA.123.068107. Epub 2024 May 16.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer 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. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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
82 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sildenafil citrate in people with Pulmonary Arterial Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 82 sites in 23 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Germany, Thailand, Ukraine, Serbia and 18 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2022). 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?
Overall Survival (time frame: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060487, which also lists 1 linked publication.
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 13 May 2022.