Pulmonary Arterial HypertensionPhase 4NCT00367770
BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
A Phase 4 study testing Tracleer® in people with Pulmonary Arterial Hypertension, run by Actelion at 17 sites in 11 countries.
Trial summary
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Tracleer®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 17 sitesin 11 countries
- Study dates
- Jan 2004to Dec 2005
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study.
- For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended; intrauterine devices (IUDs); oral or implanted contraceptives, if used in combination with a barrier method.
- Patients providing written informed consent.
Who cannot join
- Patients who withdrew prematurely from BREATHE-5, AC-052-405.
- Patients who are pregnant or nursing.
- Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
- Patients with AST and/or ALT values greater than 3 times the upper limit of normal.
- Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the study).
- Patients with systolic blood pressure < 85 mm Hg.
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- Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or are receiving another investigational product.
- Patients active on organ transplant list.
- Patients who are receiving or expected to receive glyburide, cyclosporin A or tacrolimus.
- Patients not able to comply with the protocol or adhere to therapy.
Trial locations and contacts
17 sites in 11 countries.
17 sites in 11 countries
United States2 sites
BACH Pulmonary Hypertension Service
Boston, Massachusetts, 02115
Texas Children's Hospital
Houston, Texas, 77030-2303
Australia2 sites
Royal Prince Alfred Hospital - Central Clinical School
Camperdown, NSW 2050
The Royal Melbourne Hospital
Victoria, 3050
Canada2 sites
The Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Germany2 sites
Herzzentrum NRW
Bad Oeynhausen, D-32545
Deutsches Herzzentrum Munchen
München, D-80636
Italy2 sites
University of Bologna
Bologna, 40138
San Matteo Hospital
Pavia, 27100
United Kingdom2 sites
Scottish Vascular Unit - Western Infirmary
Glasgow, G11 6NT
Royal Brompton Hospital
London, SW3 6NP
Spain1 site
Unidad Medico Quirurgica de Cardiologia - Edificio General
Madrid, 28046
About this study
Official title: A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.
Read the detailed description
This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Tracleer®
- Keywords
- bosentan, PAH related to Eisenmenger physiology, Tracleer
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracleer®Drug
Patients will receive up to 125 mg b.i.d. of Tracleer.
| Study group | Role | What they receive |
|---|---|---|
| Tracleer | Experimental | The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated. Receives: Drug: Tracleer® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute Walk Distance
Measured: from baseline to week 24
Change in Borg Dyspnea Index
Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
Measured: from baseline to week 24
Number of Participants With a Change in WHO Functional Class
Number of participants with a change in WHO functional class from baseline to week 24.
A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.
Measured: from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startJan 2004
- Primary completionDec 2005
- Study completionDec 2005
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Landzberg, MD, Study chair, BACH Pulmonary Hypertension Service, Boston, U.S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367770
- Sponsor's protocol ID
- AC-052-409
- Status last verified
- Jul 2016
- First submitted
- 21 Aug 2006
- Last updated
- 22 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
- ClinicalTrials.gov ID
- NCT00367770
- Acronym / sponsor ID
- AC-052-409
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- bosentan, PAH related to Eisenmenger physiology, Tracleer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 23 Aug 2006 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.
Detailed description
This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracleer | Experimental | Drug: Tracleer®The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study.
- For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended; intrauterine devices (IUDs); oral or implanted contraceptives, if used in combination with a barrier method.
- Patients providing written informed consent.
Key exclusion criteria (10 listed)
- Patients who withdrew prematurely from BREATHE-5, AC-052-405.
- Patients who are pregnant or nursing.
- Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
- Patients with AST and/or ALT values greater than 3 times the upper limit of normal.
- Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the 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 |
|---|---|---|
| Tracleer®Patients will receive up to 125 mg b.i.d. of Tracleer. | Drug | Tracleer |
Primary outcome
Change in 6-minute Walk Distance
Time frame: from baseline to week 24
Change in Borg Dyspnea Index
Time frame: from baseline to week 24
Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
Number of Participants With a Change in WHO Functional Class
Time frame: from baseline to week 24
Number of participants with a change in WHO functional class from baseline to week 24. A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael Landzberg, MD study chair
BACH Pulmonary Hypertension Service, Boston, U.S.A.
17 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tracleer® in people with Pulmonary Arterial Hypertension, run by Actelion at 17 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 3 inclusion and 10 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia, Canada, Germany, Italy 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 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 15 Aug 2016). 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 6-minute Walk Distance (time frame: from baseline to week 24). The study lists 3 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 22 Sep 2016.