Prospective, multicenter, open-label study evaluating the effects of first-line oral combination therapy of macitentan and tadalafil in patients with newly diagnosed pulmonary arterial hypertension. - OPTIMA

ACTELION Pharmaceuticals France0 sites46 target enrollmentAugust 5, 2015

Overview

No summary available.

Registry

who.int

Start Date

August 5, 2015

End Date

September 10, 2018

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

ACTELION Pharmaceuticals France

•1\.Signed informed consent prior to any study\-mandated procedure.
•2\.Male or female \= 18 and \= 75 years of age at screening.
•3\.Initial PAH diagnosis \< 6 months prior to Day 1\.
•4\.Right heart catheterization (RHC) performed between Day \-28 and Day 1 (RHC data obtained at the study site within this time frame, but before the study, i.e., before signed informed consent, are acceptable), meeting all the following criteria:
•Resting mean pulmonary arterial pressure (mPAP) \= 25 mmHg.
•Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) \= 15 mmHg.
•PVR \= 400 dyn·sec/cm5 (\= 5 Wood units) if PCWP \< 12 mmHg OR PVR \= 500 dyn·sec/cm5 (\= 6\.25 Wood units) if PCWP in \[12\-15] mmHg.
•Negative vasoreactivity test mandatory in idiopathic PAH (at this or a previous RHC).
•5\.World Health Organization (WHO) Functional Class (FC) II to III.
•6\.PAH etiology belonging to one of the following groups:

•1\.Any PAH\-specific drug therapy \[e. g. any endothelin receptor antagonist, phosphodiesterase\-5 inhibitors (PDE\-5i), soluble guanylate cyclase stimulator, prostacyclin, prostacyclin analog, or prostacyclin receptor agonist] at any time prior to Day 1 (single\-dose administration for vasoreactivity testing is permitted; previous iloprost used intermittently for the treatment of digital ulcers or Raynaud’s phenomenon is permitted if stopped \> 6 months prior to Day 1\).
•2\.Subjects who changed the dose or discontinued calcium channel blockers within 3 months prior to Day 1\.
•3\.Initiation of diuretics within 1 week prior to RHC.
•4\.Subjects on oral diuretics in whom the dose has not been stable for at least 1 week prior to RHC.
•5\.Treatment with other PDE\-5i for erectile dysfunction.
•6\.Treatment with strong inducers of CYP3A4 (e.g., carbamazepine, rifampin, rifampicin, rifabutin, rifapentin, phenobarbital, phenytoin, and St. John’s wort) \= 28 days prior to Day 1\.
•7\.Treatment with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, boceprevir, telaprevir, saquinavir, lopinavir, fosamprenavir, darunavir, tipranavir, atazanavir, nelfinavir, amprenavir, indinavir) \= 28 days prior to Day 1\.
•8\.History of priapism.
•9\.Significant aortic and mitral valve disease.
•10\.Pericardial constriction.