To assess the long-term safety and tolerability of selexipag (ACT-293987) in patients with 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 3 days after study drug discontinuation.
* Treatment-emergent SAEs up to 3 days after study drug discontinuation.
* AEs leading to premature discontinuation of study drug.
Background summary
The medication that is tested in this research is called selexipag
(ACT-293987). It is a non-prostanoid IP receptor agonist. It is much more
specific and more potent in the activation of the human IP receptor then the
currently available IP receptor agonists.
Patients with PAH have been shown to have deficiency of prostacyclin and of
PGI2 synthase causing an imbalance in prostacyclin (PGI2) and thromboxane A2
(TXA2), it's physiological antagonist. These findings led to the rationale that
targeting the PGI2 pathway with IP receptor agonists could be benificial.
Prostacyclin (epoprostenol) and analogs like treprostinil (intravenous,
subcutaneous and inhaled) and iloprost (inhaled) have already been approved for
PHA. An orally available medicinal product, such as selexipag (ACT-293987), can
provide a significant contribution in the treatment options for these patients.
Study objective
To assess the long-term safety and tolerability of selexipag (ACT-293987) in
patients with pulmonary arterial hypertension (PAH).
Study design
Multicentre, open-label (OL) extension, single-arm, Phase 3 study.
Intervention
Each patient who has completed the double-blind study AC-065A302 as scheduled
per protocol will be using selexipag (ACT-293987) at his/her individual highest
tolerated dose.
Dose: oral / tablet / twice daily.
Study burden and risks
At visit 1 a physical examination and laboratory analysis will be done. For
women of child baring potential a pregnacy test will be done.
Should visit 1 be at the same time as the GRIPHON End of Study visit then this
visit will also be visit 1 for the extension study.
On week 4, week 8 and week 16 a physical examination and laboratory analysis
will be done. For women of child baring potential a pregnacy test will be done.
On month 6 and furthermore during the 6-monthly visits a physical examination
and laboratory analysis will be done. For women of child baring potential a
pregnacy test will be done.
At the end of study visit (EOS visite) a physical examination and laboratory
analysis will be done. For women of child baring potential a pregnacy test will
be done.
Gewerbestrasse 16
Allschwil CH-4123
CH
Gewerbestrasse 16
Allschwil CH-4123
CH
Listed location countries
Age
Inclusion criteria
- Signed informed consent prior to initiation of any study-mandated procedure.
- Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study).
- Women of child-bearing potential included in study AC-065A303 must use a reliable method of contraception (with a failure rate of less than 1% per year) until one month after study drug discontinuation.
Exclusion criteria
- Pediatric patients (i.e., < 18 years of age).
- Patients who are not able to perform the Visit 1 of AC-065A303/GRIPHON OL within 2 weeks (i.e., 14 days) of the last visit in AC-065A302/GRIPHON.
- Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
- Females who plan to become pregnant during the study, or are breastfeeding.
- 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 selexipag (ACT-293987) 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 | EUCTR2009-014992-31-NL |
| ClinicalTrials.gov | NCT01112306 |
| CCMO | NL30709.029.10 |