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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00319111 |
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Date of registration:
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26/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
BENEFIT OL |
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Scientific title:
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Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222) |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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151 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00319111 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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Czech Republic
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France
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Germany
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Italy
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Netherlands
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Poland
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Spain
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients having completed the 16-week treatment period of protocol AC-052-366
(NCT00313222)
- Signed informed consent
Exclusion Criteria:
- Any major violation of protocol AC-052-366 (NCT00313222)
- Pregnancy or breast-feeding
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Intervention(s)
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Drug: bosentan
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Primary Outcome(s)
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Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)
[Time Frame: Until discontinuation of study drug, up to 3.3 years]
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Time to Clinical Worsening up to End-of-study
[Time Frame: Until discontinuation of study drug, up to 3.3 years]
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Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance
[Time Frame: Until discontinuation of study drug, up to 3.3 years]
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Change From Baseline to All Assessed Time Points in Borg Dyspnea Index
[Time Frame: Until discontinuation of study drug, up to 3.3 years]
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Secondary Outcome(s)
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Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation
[Time Frame: 28 days after discontinuation of study drug, up to 3.3 years]
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Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication
[Time Frame: Until discontinuation of study drug, up to 3.3 years]
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Occurrence of Liver Function Test and Hemoglobin Abnormality
[Time Frame: Until discontinuation of study drug, up to 3.3 years]
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Secondary ID(s)
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AC-052-370
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BENEFIT OL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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