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

NCT00319111 | Completed Phase 3 Results

• 2 other identifiers: AC-052-370BENEFIT OL
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension; bosentan; BENEFIT; CTEPH; inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Outcome Measures

Primary Outcomes (4)

• Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance

  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.

  Until discontinuation of study drug, up to 3.3 years

• Change From Baseline to All Assessed Time Points in Borg Dyspnea Index

  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 \[maximum ever experienced\]).

  Until discontinuation of study drug, up to 3.3 years

• Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)

  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.

  Until discontinuation of study drug, up to 3.3 years

• Time to Clinical Worsening up to End-of-study

  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.

  Until discontinuation of study drug, up to 3.3 years

Secondary Outcomes (3)

• Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication

  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

  28 days after discontinuation of study drug, up to 3.3 years

• Occurrence of Liver Function Test and Hemoglobin Abnormality

  Until discontinuation of study drug, up to 3.3 years

Study Arms (1)

Bosentan

EXPERIMENTAL

Open label bosentan treatment

Drug: bosentan

Interventions

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)

Bosentan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222)
• Signed informed consent

You may not qualify if:

• Any major violation of protocol AC-052-366 (NCT00313222)
• Pregnancy or breast-feeding

Sponsors & Collaborators

• Actelion: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Loïc Perchenet PhD/Clinical Trial Leader
• Organization: Actelion Pharmaceuticals Ltd

+41 61 565 6457

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2006
• First Posted: April 27, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 4, 2025
• Results First Posted: December 31, 2012

Record last verified: 2025-01