Hypertension, PulmonaryPhase 3NCT00644605
A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension
A Phase 3 study testing sildenafil in people with Hypertension, Pulmonary, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 68 sites in 23 countries.
Trial summary
To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 68 sitesin 23 countries
- Study dates
- Oct 2002to Nov 2003
- 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
- Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.
Who cannot join
- Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.
Trial locations and contacts
68 sites in 23 countries.
68 sites in 23 countries
United States24 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Aurora, Colorado, 80010
Pfizer Investigational Site
Baltimore, Maryland, 21205
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, 60612
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, 90095
Pfizer Investigational Site
Milwaukee, Wisconsin, 53215
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, 92037
Pfizer Investigational Site
Shreveport, Louisiana, 71103
Pfizer Investigational Site
Torrance, California, 90502
Pfizer Investigational Site
Torrance, California, 90509
Germany5 sites
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Giessen, 35385
Pfizer Investigational Site
Giessen, 35392
Pfizer Investigational Site
Hanover, 30625
Pfizer Investigational Site
Leipzig, 04103
Poland4 sites
Pfizer Investigational Site
Katowice, 40-057
Pfizer Investigational Site
Warsaw, 01-138
Pfizer Investigational Site
Warsaw, 03-709
Pfizer Investigational Site
Zabrze, 41-800
United Kingdom4 sites
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
HIGH Heaton, Newcastle-upon-tyne, NE7 7DW
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, CB3 8RE
Pfizer Investigational Site
Sheffield, South Yorkshire, S10 2JF
Italy3 sites
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Pisa, 56124
Pfizer Investigational Site
Pisa, 56126
South Africa3 sites
Pfizer Investigational Site
Cape Town, 7700
Pfizer Investigational Site
Johannesburg, 2193
Pfizer Investigational Site
Parow
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, Pest County, 1529
Pfizer Investigational Site
Zalaegerszeg, Zala County, 8900
Israel2 sites
Pfizer Investigational Site
Petah Tikva, 49100
Pfizer Investigational Site
Tel HaShomer, 52621
Sweden2 sites
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Mölndal, 431 80
About this study
Official title: A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.
- Conditions
- Hypertension, Pulmonary
- Being tested
- sildenafil, placebo
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
sildenafilDrug
sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
placeboDrug
placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
sildenafilDrug
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: sildenafil |
| Arm 2 | Active comparator | Not described Receives: Drug: sildenafil |
| Arm 3 | Active comparator | Not described Receives: Drug: sildenafil |
| Arm 4 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).
Measured: Week 12
Secondary outcomes (9)
Change from baseline in mean pulmonary arterial pressure
Measured: Week 12
Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy)
Measured: Week 0 to 12
Change from baseline in the BORG dyspnoea score
Measured: Week 12
Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class
Measured: Week 12
Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition)
Measured: Week 4 and Week 12
Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression)
Measured: Week 4 and Week 12
Patient overall preference assessment
Measured: Week 12
Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension
Measured: throughout the study
Change from baseline in hemodynamic parameters
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startOct 2002
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies 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, Investigator
- Enrolment
- 275 participants (estimated)
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
- NCT00644605
- Sponsor's protocol ID
- A1481140
- Status last verified
- Jan 2021
- First submitted
- 20 Mar 2008
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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 22354598
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-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
- ClinicalTrials.gov ID
- NCT00644605
- Acronym / sponsor ID
- A1481140
- Conditions
- Hypertension, Pulmonary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Nov 2003 (actual)
- First posted
- 27 Mar 2008 (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.
To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: sildenafil |
| Arm 2 | Active comparator | Drug: sildenafil |
| Arm 3 | Active comparator | Drug: sildenafil |
| Arm 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.
Key exclusion criteria (1 listed)
- Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.
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 |
|---|---|---|
| sildenafilsildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks | Drug | Arm 2 |
| sildenafilsildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID | Drug | Arm 3 |
| placeboplacebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks | Drug | Arm 4 |
| sildenafilsildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks | Drug | Arm 1 |
Primary outcome
Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).
Time frame: Week 12
9 secondary outcomes
Change from baseline in mean pulmonary arterial pressure
Time frame: Week 12
Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy)
Time frame: Week 0 to 12
Change from baseline in the BORG dyspnoea score
Time frame: Week 12
Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class
Time frame: Week 12
Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition)
Time frame: Week 4 and Week 12
Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression)
Time frame: Week 4 and Week 12
Patient overall preference assessment
Time frame: Week 12
Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension
Time frame: throughout the study
Change from baseline in hemodynamic parameters
Time frame: Week 12
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.
- 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
68 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sildenafil in people with Hypertension, Pulmonary, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 68 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 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 68 sites in United States, Germany, Poland, United Kingdom, Italy 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. Some participants in this study may receive a placebo. 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?
Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test). (time frame: Week 12). 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 NCT00644605, 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.