Pulmonary HypertensionPhase 3NCT00159861
The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH
A Phase 3 study testing Sildenafil citrate in people with Pulmonary Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 52 sites in 11 countries.
Trial summary
Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Sildenafil citrate
- How many people
- 267 participants
- Where
- 52 sitesin 11 countries
- Study dates
- Jul 2003to Jan 2006
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pulmonary arterial hypertension caused by primary PAH, associated with connective tissue disease or following surgical repair of a congenital heart lesion
Who cannot join
- PH other than PAH
Trial locations and contacts
52 sites in 11 countries.
52 sites in 11 countries
United States33 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0769
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Denver, Colorado, 80262
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Kansas City, Kansas, 66160
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Los Angeles, California, 90073
Pfizer Investigational Site
Milwaukee, Wisconsin, 53215
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
Milwaukee, Wisconsin, 53277
Pfizer Investigational Site
Nashville, Tennessee, 37232-5735
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Omaha, Nebraska, 68105
Pfizer Investigational Site
Omaha, Nebraska, 68198-2125
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Providence, Rhode Island, 02903
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Salt Lake City, Utah, 84143
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Torrance, California, 90502
Pfizer Investigational Site
Torrance, California, 90509
Canada5 sites
Pfizer Investigational Site
Edmonton, Alberta, T6G 2B7
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4E9
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4W7
Pfizer Investigational Site
Toronto, Ontario, M5G 2N2
France3 sites
Pfizer Investigational Site
Clamart, 92141
Pfizer Investigational Site
Grenoble, 38043
Pfizer Investigational Site
Vandœuvre-lès-Nancy
Netherlands2 sites
Pfizer Investigational Site
Amsterdam, 1081 HV
Pfizer Investigational Site
Nieuwegein, 3435CM
Spain2 sites
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Madrid, 28041
United Kingdom2 sites
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, CB3 8RE
About this study
Official title: A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.
Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension
- Conditions
- Pulmonary Hypertension
- Being tested
- Sildenafil citrate
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil citrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorized Change From Baseline in 6-Minute Walking Distance
Number of subjects with categorized change in 6-minute walking distance. Distance that a subject could walk in 6-minutes at a comfortable pace with as many breaks as needed. Performed as close to trough levels of sildenafil as possible (just before dosing; at least 4 hours after the previous dose of study drug). Scores for categorized changes for missing visits were imputed as the worse score of its non-missing neighbors. If a visit was missing and there was no subsequent score, the score was coded to missing.
Measured: 1 Year, 2 Year, 3 Year
Secondary outcomes (7)
Survival Status
Yearly survival status: number of subjects who survived, discontinued, and died. Analysis includes post-treatment visit data from subjects who discontinued study treatment. Time to death was taken relative to the first dose of study treatment in A1481141, and was censored on the last day the subject was known to be alive in A1481141 or A1481153.
Measured: 1, 2, 3, 4, and 5 years
Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class
Pulmonary hypertension (PH) criteria: Class I: PH without limitation of physical activity (PA) (no undue dyspnea, fatigue, chest pain, near syncope); Class II: PH with slight limitation in PA, comfortable at rest, ordinary PA causes undue dyspnea, fatigue, chest pain, near syncope; Class III: PH with marked limitation in PA, comfortable at rest, less than ordinary activity causes undue dyspnea, fatigue, chest pain or syncope; Class IV: PH with inability to carry out PA without symptoms, signs of right heart failure, dyspnea or fatigue may be present at rest, discomfort increased by any PA.
Measured: 1 Year, 2 Year, 3 Year
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Change from baseline = score at observation minus score at baseline.
Measured: Baseline, Month 15, Month 27, Month 39
Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Measured: Baseline, Month 15, Month 27, Month 39
Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Measured: Baseline, Month 15, Month 27, Month 39
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score
Subject-rated measure of health status (36 items): 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, mental health), 2 summary scores (physical component, mental component), and a self-evaluated change in health status. Change from Baseline in SF-36 Health Transition score at each visit. I=much better than 1 year ago; II=somewhat better than 1 year ago; III=about the same as 1 year ago; IV=somewhat worse than 1 year ago; V=much worse than 1 year ago
Measured: Baseline, Month 15, Month 27, Month 39
Change From Baseline in BORG Dyspnea Score
BORG Dyspnea score: change from core study Baseline. Subject rating of maximum degree of dyspnea experienced at any time during the 6-Minute Walk Test. Range: 0 (no breathlessness at all) to 10 (maximum breathlessness).
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2003
- Study completionJan 2006
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159861
- Sponsor's protocol ID
- A1481141
- Status last verified
- Jan 2021
- First submitted
- 8 Sep 2005
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Simonneau G, Rubin LJ, Galie N, Barst RJ, Fleming TR, Frost A, Engel P, Kramer MR, Serdarevic-Pehar M, Layton GR, Sitbon O, Badesch DB; PACES Study Group. Long-term sildenafil added to intravenous epoprostenol in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2014 Jul;33(7):689-97. doi: 10.1016/j.healun.2014.02.019. Epub 2014 Feb 22.
PubMed 24815795
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
- A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.
- ClinicalTrials.gov ID
- NCT00159861
- Acronym / sponsor ID
- A1481141
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2003
- Study completion
- Jan 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 12 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pulmonary arterial hypertension caused by primary PAH, associated with connective tissue disease or following surgical repair of a congenital heart lesion
Key exclusion criteria (1 listed)
- PH other than PAH
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 citrate | Drug | – |
Primary outcome
Categorized Change From Baseline in 6-Minute Walking Distance
Time frame: 1 Year, 2 Year, 3 Year
Number of subjects with categorized change in 6-minute walking distance. Distance that a subject could walk in 6-minutes at a comfortable pace with as many breaks as needed. Performed as close to trough levels of sildenafil as possible (just before dosing; at least 4 hours after the previous dose of study drug). Scores for categorized changes for missing visits were imputed as the worse score of its non-missing neighbors. If a visit was missing and there was no subsequent score, the score was coded to missing.
7 secondary outcomes
Survival Status
Time frame: 1, 2, 3, 4, and 5 years
Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class
Time frame: 1 Year, 2 Year, 3 Year
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)
Time frame: Baseline, Month 15, Month 27, Month 39
Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score
Time frame: Baseline, Month 15, Month 27, Month 39
Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score
Time frame: Baseline, Month 15, Month 27, Month 39
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score
Time frame: Baseline, Month 15, Month 27, Month 39
Change From Baseline in BORG Dyspnea Score
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36
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.
- Derived from this study: PubMed 24815795Simonneau G, Rubin LJ, Galie N, Barst RJ, Fleming TR, Frost A, Engel P, Kramer MR, Serdarevic-Pehar M, Layton GR, Sitbon O, Badesch DB; PACES Study Group. Long-term sildenafil added to intravenous epoprostenol in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2014 Jul;33(7):689-97. doi: 10.1016/j.healun.2014.02.019. Epub 2014 Feb 22.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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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
52 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil citrate in people with Pulmonary Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 52 sites in 11 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 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.
Where is the study taking place?
The record lists 52 sites in United States, Canada, France, Netherlands, Spain and 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 12 Jan 2011). 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?
Categorized Change From Baseline in 6-Minute Walking Distance (time frame: 1 Year, 2 Year, 3 Year). 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 NCT00159861, 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 1 Feb 2021.