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Completed

NCT Number: NCT00319111

Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bosentan

Drug

Oral bosentan

  • Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
  • Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)

Primary outcomes

  1. 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.

  2. 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]).

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)

Acronym: BENEFIT OL

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2006
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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