ncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extensio
- Conditions
- Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis
- Registration Number
- EUCTR2004-000745-37-GB
- Lead Sponsor
- Actelion Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
·Patients with PAH who have completed their participation in the preceding TRUST study with bosentan.
·Provide written informed consent.
·Female patients must be either postmenopausal or surgically or naturally sterile. Women of childbearing potential must have a negative pre-enrollment pregnancy test and use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.Reliable methods of contraception are:
Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
Intra-uterine devices.
Oral, injectable or implantable contraceptives only in combination with a barrier method.
Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception. Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
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
Eligible patients must meet none of the following exclusion criteria:
·Moderate to severe hepatic impairment i.e., Child-Pugh Class B or C
·Baseline liver aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT), greater than 3 times the upper limit of normal ranges.
·Known hypersensitivity to bosentan or any of the excipients of the formulation.
·Treatment with glibenclamide, any calcineurin inhibitor.
·Pregnancy or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effects of bosentan treatment on long-term survival in patients with PAH related to connective tissue disease;Secondary Objective: ;Primary end point(s): EFFICACY ENDPOINTS:<br><br>. Time to death,<br>. Time to change of PAH therapy,<br>. Change from baseline to one year and end of study in WHO functional class.<br><br>SAFETY / TOLERABILITY ENDPOINTS:<br><br>·Adverse events up to 24 hours after study drug discontinuation,<br>·Adverse events leading to premature discontinuation of study drug,<br>.Serious adverse events up to 28 days after study drug discontinuation,<br>·Changes from baseline to end of treatment in vital signs.
- Secondary Outcome Measures
Name Time Method