Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (BENEFIT OL)
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|ClinicalTrials.gov Identifier: NCT00319111|
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : December 31, 2012
Last Update Posted : December 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: bosentan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||April 2009|
Open label bosentan treatment
- 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 ]Exercise capacity was assessed using the 6MWT. Area used for testing had to be a minimum of 30m in length and 2-3m in width, with 3m gradations. Areas were well ventilated with air temperature controlled. The test was administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6min period. If the test was stopped before 6 minutes, the main reason for stopping the test was recorded. The tester measured the distance walked by patients during the timed 6min period.
- Change From Baseline to All Assessed Time Points in Borg Dyspnea Index [ Time Frame: Until discontinuation of study drug, up to 3.3 years ]Maximal dyspnea during the walk test was assessed by the patient using the Borg dyspnea index. Immediately following each walk test, patients rated perceived maximal breathlessness during the walk test on a 12-point scale (0 [nothing at all], 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 [maximum ever experienced]).
- 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 ]
Disease severity was assessed by WHO classification of PH criteria:
Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope.
Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.
Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.
Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
- Time to Clinical Worsening up to End-of-study [ Time Frame: Until discontinuation of study drug, up to 3.3 years ]An event of clinical worsening was defined as death during the treatment period, a treatment-emergent adverse event that led to permanent discontinuation of study treatment and with outcome death, hospitalization due to worsening pulmonary hypertension, or lung transplantation. Patients are censored at 1 day after the end of treatment or at day of pulmonary endarterectomy if earlier.
- 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 ]
- 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 ]
- Occurrence of Liver Function Test and Hemoglobin Abnormality [ Time Frame: Until discontinuation of study drug, up to 3.3 years ]Number of patients with an increase in liver aminotransferases to >3 times upper limit of normal (ULN) or a decrease in hemoglobin concentration to ≤10 g/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319111