Pulmonary HypertensionPhase 3NCT00454207
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
A Phase 3 study testing sildenafil citrate (UK-92,480) in people with Pulmonary Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in Japan.
Trial summary
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1) 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 (UK-92,480)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 8 sitesJapan
- Study dates
- Apr 2007to Feb 2009
- 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
- Subjects aged 16 and over, and classified as having pulmonary arterial hypertension
- Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
- Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m
Who cannot join
- Significant Hepatic and/or renal disorder
- Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
- Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Chiba, Chiba
Pfizer Investigational Site
Hamamatsu, Shizuoka
Pfizer Investigational Site
Kanazawa, Ishikawa-ken
Pfizer Investigational Site
Okayama, Okayama-ken
Pfizer Investigational Site
Shinjuku-ku, Tokyo
Pfizer Investigational Site
Tokyo
Pfizer Investigational Site
Tsu, Mie-ken
About this study
Official title: A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)
- Conditions
- Pulmonary Hypertension
- Being tested
- sildenafil citrate (UK-92,480)
- Keywords
- Pulmonary Arterial Hypertension, PAH
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafil citrate (UK-92,480)Drug
sildenafil citrate (UK-92,480)
| Study group | Role | What they receive |
|---|---|---|
| sildenafil citrate (UK-92,480) | Experimental | sildenafil citrate 20 mg TID Receives: Drug: sildenafil citrate (UK-92,480) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.
Measured: Baseline, Week 12
Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.
Measured: Baseline, Week 12
Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline
Measured: Baseline, Week 12
Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Cardiac output at Week 12 minus cardiac output at baseline
Measured: Baseline, week 12
Secondary outcomes (30)
Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I
Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline.
The 6-minute walk distance:Total distance walked during the 6- minute walk test.
Measured: Baseline, Week 8
Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.
Measured: Baseline, Week 12
Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.
Measured: Baseline, Week 12
Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.
Measured: Baseline, Week 12
Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.
Measured: Baseline, Week 12
Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3.
Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline.
Measured: Baseline, Week 12
Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.
Measured: Baseline, Week 12
Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline.
Measured: Baseline, Week 12
Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Cardiac index at Week 12 minus cardiac index at baseline.
Measured: Baseline, Week 12
Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Heart rate at Week 12 minus heart rate at baseline.
Measured: Baseline, Week 12
Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.
Measured: Baseline, Week 12
Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.
Measured: Baseline, Week 12
Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.
Measured: baseline, Week 12
Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.
Measured: Baseline, Week 12
Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.
Measured: Baseline, Week 12
Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.
Measured: baseline, Week 12
Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.
Measured: Baseline, Week 12
Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I
The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).
Measured: Baseline, Week 12
Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I
Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.
Measured: Baseline, Week 8, Week 12
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I
Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline
Measured: Baseline, Week 4, Week 8, Week 12
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.
Measured: Baseline, Week 12
Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).
Measured: Baseline, Week 12
Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.
Measured: Baseline, Week 12
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II
Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline
Measured: Baseline, Week 12
Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320
The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
The Average Plasma Concentration (Css,av) of Sildenafil at Steady State
The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
The Average Plasma Trough Concentration (Ctrough) of Sildenafil
The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
The total number of participants with laboratory test abnormalities without regard to baseline abnormality.
Measured: Baseline up to 1.3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- Study completionFeb 2009
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 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
- 44 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
- NCT00454207
- Sponsor's protocol ID
- A1481252
- Other IDs
- JapicCTI-070381
- Status last verified
- Jan 2021
- First submitted
- 28 Mar 2007
- Last updated
- 21 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00454207
- Acronym / sponsor ID
- A1481252
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Arterial Hypertension, PAH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Mar 2007 (estimated)
- Results
- Posted 9 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sildenafil citrate (UK-92,480) | Experimental | Drug: sildenafil citrate (UK-92,480)sildenafil citrate 20 mg TID |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 16 and over, and classified as having pulmonary arterial hypertension
- Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
- Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m
Key exclusion criteria (3 listed)
- Significant Hepatic and/or renal disorder
- Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
- Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole
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 (UK-92,480)sildenafil citrate (UK-92,480) | Drug | sildenafil citrate (UK-92,480) |
Primary outcome
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.
Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.
Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline
Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, week 12
Change：Cardiac output at Week 12 minus cardiac output at baseline
30 secondary outcomes
Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 8
Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: baseline, Week 12
Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: baseline, Week 12
Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 12
Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 8, Week 12
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I
Time frame: Baseline, Week 4, Week 8, Week 12
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Time frame: Baseline, Week 12
Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Time frame: Baseline, Week 12
Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Time frame: Baseline, Week 12
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II
Time frame: Baseline, Week 12
Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
The Average Plasma Concentration (Css,av) of Sildenafil at Steady State
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
The Average Plasma Trough Concentration (Ctrough) of Sildenafil
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame: Baseline up to 1.3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sildenafil citrate (UK-92,480) in people with Pulmonary Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in Japan.
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 3 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 21 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 8 sites in Japan. 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 9 Sep 2010). 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 in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I (time frame: Baseline, Week 12). 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 21 Feb 2021.