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Register:	EUCTR
Last refreshed on:	27 May 2013
Main ID:	EUCTR2005-002900-40-AT
Date of registration:	07/11/2005
Prospective Registration:	No
Primary sponsor:	Actelion Pharmaceuticals Ltd.
Public title:	BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL
Scientific title:	BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL
Date of first enrolment:	15/08/2005
Target sample size:	128
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002900-40
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:

Countries of recruitment
Austria	Czech Republic	Germany	Italy	Spain	United Kingdom

Contacts

Name:
Address:
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Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
· Patients having completed the 16-week treatment period of protocol AC-052-366/BENEFIT

· Signed informed consent prior to initiation of any study-mandated procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
· Any major violation of protocol AC-052-366/BENEFIT

· Pregnancy or breast-feeding

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Intervention(s)

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 157212-55-0
Current Sponsor code: Ro-47-0203/029
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5-

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 157212-55-0
Current Sponsor code: Ro-47-0203/029
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Primary end point(s): Efficacy endpoints:

· Change from baseline to all assessed time points in 6-minute walk test distance.

· Change from baseline to all assessed time points in Borg dyspnea index.

· Change from baseline to all assessed time points in NYHA class.

· Time to clinical worsening up to End-of-Study.
Clinical worsening is defined as:
o Death, or
o Lung transplantation, or
o Hospitalization for worsening of pulmonary hypertension.
For patients who were in the placebo arm of the BENEFIT study, the study baseline values are the EOS values of BENEFIT, unless the patient is enrolled more than 4 weeks after this visit. In this latter case the baseline assessments are performed during the enrollment visit.
For patients who were in the bosentan arm of the BENEFIT study, the study baseline values are the baseline values of BENEFIT.

Safety and tolerability enddpoints:
· Adverse event(s) leading to premature discontinuation of study medication.

· Serious adverse events up to 28 days after study medication discontinuation.

· Occurrence of liver function test (ALT and/or AST) abnormality (> 3 and <= 5 x ULN; > 5 and <= 8 x ULN; > 8 x ULN) and hemoglobin abnormality (<= 8 g/dl; > 8 and <= 10 g/dl)

Main Objective: The study objectives are to collect long-term efficacy, tolerability and safety data in patients with inoperable CTEPH treated with bosentan

Secondary Objective:

Secondary Outcome(s)

Secondary ID(s)

AC-052-370

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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