Pulmonary HypertensionPhase 3NCT00159887
Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension
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 65 sites in 22 countries.
Trial summary
Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Sildenafil citrate
- How many people
- 260 participants
- Where
- 65 sitesin 22 countries
- Study dates
- Dec 2002to Feb 2007
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PAH who had completed the 12 week pivotal study
Who cannot join
- Any other patients with PAH that had not been included into the pivotal study
Trial locations and contacts
65 sites in 22 countries.
65 sites in 22 countries
United States24 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35294-0006
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Chicago, Illinois, 60637
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
La Jolla, California, 92037
Pfizer Investigational Site
La Jolla, California, 92093
Pfizer Investigational Site
Los Angeles, California, 90024
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Los Angeles, California, 90073
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Milwaukee, Wisconsin, 53215
Pfizer Investigational Site
Nashville, Tennessee, 37232-5735
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
San Diego, California, 92103-8320
Pfizer Investigational Site
Torrance, California, 90502
United Kingdom5 sites
Pfizer Investigational Site
Cambridge, CB4 9EL
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, CB3 8RE
Pfizer Investigational Site
Sheffield, South Yorkshire, S10 2JF
Germany3 sites
Pfizer Investigational Site
Giessen, 35392
Pfizer Investigational Site
Hanover, 30625
Pfizer Investigational Site
Leipzig, 04103
Italy3 sites
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Pisa, 56124
Pfizer Investigational Site
Pisa, 56126
South Africa3 sites
Pfizer Investigational Site
Parktown, 2193
Pfizer Investigational Site
Parktown West, 2193
Pfizer Investigational Site
Parow, Western Cape, 7505
Spain3 sites
Pfizer Investigational Site
Barcelona, 08035
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Madrid, 28041
Australia2 sites
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010
Pfizer Investigational Site
Melbourne, Victoria, 3004
Belgium2 sites
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Leuven, 3000
Czechia2 sites
Pfizer Investigational Site
Prague, 140 00
Pfizer Investigational Site
Prague, 140 21
Hungary2 sites
Pfizer Investigational Site
Budapest, 1529
Pfizer Investigational Site
Zalaegerszeg, 8900
Israel2 sites
Pfizer Investigational Site
Petah Tikva, 49100
Pfizer Investigational Site
Tel HaShomer, 52621
Malaysia2 sites
Pfizer Investigational Site
Kuala Lumpur, 59100
Pfizer Investigational Site
Petaling Jaya, 46200
Mexico2 sites
Pfizer Investigational Site
Tlalpan, Mexico DF, 14080
Pfizer Investigational Site
Tlalpan Mexico, Mexico City, 14050
Poland2 sites
Pfizer Investigational Site
Warsaw, 01-138
Pfizer Investigational Site
Zabrze, 41-800
About this study
Official title: A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.
Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate 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.
Safety
Standard safety data
Efficacy
6-Minute Walk Test
BORG Dyspnoea Score
WHO Functional Class
Quality of Life SF-36 and EQ-5D
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 startDec 2002
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 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
- NCT00159887
- Sponsor's protocol ID
- A1481142
- Status last verified
- Jan 2021
- First submitted
- 8 Sep 2005
- Last updated
- 1 Feb 2021
- Results posted
- No
Publications
Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.
PubMed 22354598Rubin LJ, Badesch DB, Fleming TR, Galie N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.
PubMed 21546436
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 Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.
- ClinicalTrials.gov ID
- NCT00159887
- Acronym / sponsor ID
- A1481142
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Feb 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- 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.
Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with PAH who had completed the 12 week pivotal study
Key exclusion criteria (1 listed)
- Any other patients with PAH that had not been included into the pivotal study
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
Safety
Standard safety data
Efficacy
6-Minute Walk Test
BORG Dyspnoea Score
WHO Functional Class
Quality of Life SF-36 and EQ-5D
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 1 Feb 2021.
- Derived from this study: PubMed 22354598Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.
- Derived from this study: PubMed 21546436Rubin LJ, Badesch DB, Fleming TR, Galie N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.
- 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
65 sites in 22 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 65 sites in 22 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 65 sites in United States, United Kingdom, Germany, Italy, South Africa and 17 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?
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?
Safety. The study lists 7 primary outcomes in all. 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 NCT00159887, which also lists 2 linked publications.
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.