To assess the long-term safety and tolerability of macitentan in patients with symptomatic pulmonary arterial hypertension (PAH).
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
No primary efficacy endpoint is considered for this open label extension study.
Secondary outcome
Safety and Tolerability endpoints
• Treatment-emergent AEs up to 28 days after study drug discontinuation.
• Treatment-emergent SAEs up to 28 days after study drug discontinuation.
• AEs leading to premature discontinuation of study drug.
• 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) up to 28 days after study drug discontinuation.
Background summary
The medication that is tested in this research is called macitentan . It is a
new, oraly active, dual endothelin receptor antagonist. Endothelin is produced
in increased amounts in patients with pulmonary arterial hypertension. It is
one of the most potent vasoconstrictors. By blocking the action of endothelin,
macitentan may reduce the blood pressure in the lung and improve activity
level and wellbeing.
The study medication, macitentan , belongs to the same class of drugs as
bosentan (Tracleer*), the first endothelin receptor antagonist drug registered
in 2002 for the treatment of pulmonary arterial hypertension.
macitentan is a new, oral active, non-peptide, potent dual ETa and ETb
receptor antagonist. It shows dose-dependent efficacy simular to that observed
with bosetan (Tracleer) in pre-clinical models of hypertension and PAH, but ten
times more potent.
Study objective
To assess the long-term safety and tolerability of macitentan in patients with
symptomatic pulmonary arterial hypertension (PAH).
Study design
Multicenter, Long-term, single-arm, open label extension phase III study.
Intervention
macitentan in a once daily oral dose of 10mg
Study burden and risks
At visit 1 a physical examination and laboratory analysis will be done. Should
visit 1 be at the same time as the SERAPHIN End of Study visit then this visit
will also be visit 1 for the extension study. Monthly LFTs will be done and if
applicable a pregnancy test in women of childbearing potential. Furthermore
during the 6-monthly visits and at the end of study a physical examination,
clinical laboratory test and (if applicable) a pregnancy test will be done.
Gewerbestrasse 16
Allschwil 4123
CH
Gewerbestrasse 16
Allschwil 4123
CH
Listed location countries
Age
Inclusion criteria
• Signed informed consent prior to initiation of any study-mandated procedure.
• Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or
Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
• Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
Exclusion criteria
• Any major violation of protocol AC 055 302/SERAPHIN.
• Pregnancy or breast-feeding.
• AST and/or ALT > 3 times the upper limit of the normal range.
• Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
• Known hypersensitivity to macitentan or any of the excipients.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003694-27-NL |
| CCMO | NL21145.100.08 |