Pulmonary HypertensionPhase 3NCT00091715
Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
A Phase 3 study testing bosentan in people with Pulmonary Hypertension, run by Actelion at 34 sites in 14 countries.
Trial summary
The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- bosentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 34 sitesin 14 countries
- Study dates
- Apr 2004to Feb 2011
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PAH NYHA Class II
- Significant elevation of mean pulmonary arterial pressure
- Significant elevation of pulmonary vascular resistance at rest
- Limited 6-minute walk distance
Who cannot join
- PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt
- Restrictive or obstructive lung disease
- Significant vasoreactivity
- Treatments for PAH (within 4 weeks of randomization)
Trial locations and contacts
34 sites in 14 countries.
34 sites in 14 countries
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama-Birmingham
Birmingham, Alabama, 35294
Tufts- New England Medical Center
Boston, Massachusetts, 02111
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
St. Paul University Hospital
Dallas, Texas, 75390
Harbor UCLA Medical Center
Torrance, California, 90509
Canada6 sites
University of Calgary
Calgary, Alberta, T1Y 6J4
University of Alberta
Edmonton, Alberta, T6G 2B7
Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
Victoria Medical Centre
Hamilton, Ontario, L8L 5G4
Centre de Pneumologie de L'Hospital Laval
Sainte-Foy, Quebec, G1V 4G5
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Germany6 sites
Universitat Greifswald
Greifswald, 17487
Universitat Greifswald
Greifswald
Universitarsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Universitatsklinik
Heidelberg
Universitatsklinikim Leipzig
Leipzig
Klinikum der Universitat Regensburg
Regensburg
Australia3 sites
The Prince Charles Hospital
Brisbane, 4032
Royal Prince Albert Hospital
Camperdown
St. Vincent's Hospital
Darlinghurst
Spain3 sites
Hospital Clinic
Barcelona
Hospital Valle d'Hebron
Barcelona
Hospital 12 de Octubre
Madrid
Netherlands2 sites
VU Medisch Centrum
Amsterdam
University Hospital Maastricht
Maastricht
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)
The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.
- Conditions
- Pulmonary Hypertension
- Being tested
- bosentan, placebo
- Keywords
- Pulmonary arterial hypertension, PAH, PPH, bosentan, early
- 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.
bosentanDrug
Also called Tracleer
65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study
placeboDrug
placebo for 6 months followed by an open-label period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 62.5 mg table twice a day for 4 weeks followed by 125 mg tablet twice a day for 6 months followed by an open label period until end of study. Receives: Drug: bosentan |
| 2 | Placebo comparator | placebo for 6 months followed by an open label period Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
Measured: Baseline to end of study
cardiac hemodynamics
Measured: Baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2004 (estimated)
- Study startApr 2004
- Primary completionNov 2006
- Study completionFeb 2011
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091715
- Sponsor's protocol ID
- EARLY
- Other IDs
- AC-052-364
- Status last verified
- Aug 2011
- First submitted
- 16 Sep 2004
- Last updated
- 30 Aug 2011
- Results posted
- No
Publications
Galie N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008 Jun 21;371(9630):2093-100. doi: 10.1016/S0140-6736(08)60919-8.
PubMed 18572079
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT00091715
- Acronym / sponsor ID
- EARLY
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary arterial hypertension, PAH, PPH, bosentan, early
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Sep 2004 (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.
The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bosentan62.5 mg table twice a day for 4 weeks followed by 125 mg tablet twice a day for 6 months followed by an open label period until end of study. |
| 2 | Placebo comparator | Drug: placeboplacebo for 6 months followed by an open label period |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- PAH NYHA Class II
- Significant elevation of mean pulmonary arterial pressure
- Significant elevation of pulmonary vascular resistance at rest
- Limited 6-minute walk distance
Key exclusion criteria (4 listed)
- PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt
- Restrictive or obstructive lung disease
- Significant vasoreactivity
- Treatments for PAH (within 4 weeks of randomization)
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 |
|---|---|---|
| bosentanAlso: Tracleer65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study | Drug | 1 |
| placeboplacebo for 6 months followed by an open-label period | Drug | 2 |
Primary outcome
exercise capacity
Time frame: Baseline to end of study
cardiac hemodynamics
Time frame: Baseline to end of study
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 30 Aug 2011.
- Derived from this study: PubMed 18572079Galie N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008 Jun 21;371(9630):2093-100. doi: 10.1016/S0140-6736(08)60919-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bosentan in people with Pulmonary Hypertension, run by Actelion at 34 sites in 14 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 4 inclusion and 4 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 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada, Germany, Australia, Spain and 9 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?
exercise capacity (time frame: Baseline to end of study). The study lists 2 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 NCT00091715, 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 30 Aug 2011.