Pulmonary arterial hypertension MedDRA version: 12.0 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
Conditions
Interventions
Product Name: Tezosentan
Product Code: ACT-050089 (Ro 61-0612)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tezosentan
CAS Number: 180384-58-0
Current Sponsor code:
Sponsors
Actelion Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Screening 1. Signed informed consent prior to initiation of any study-mandated procedure 2. Male and female patients 18 years of age or older 3. Patients with PAH according to one of the following subgroups of the Venice Classification Group 1: · Idiopathic (iPAH), or · Familial / heritable (FPAH), or · Associated (APAH) with collagen vascular disease 4. Modified NYHA functional class II-III Day 1 On Day 1, upon right heart catheterization (RHC), the last inclusion criteria will be checked: 5. Documented hemodynamic diagnosis of PAH by right heart catheterization on Day 1: · Resting mean pulmonary arterial pressure (mPAP) = 25 mmHg and · Resting mean PVR = 240 dyn·s·cm-5 and · Pulmonary capillary wedge pressure (PCWP) = 15 mmHg 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
Exclusion criteria: Screening 1. Patients with PAH in Venice Classification Groups 2–5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3 2. Hypotensive patients (systemic systolic blood pressure 2.5mg/dL / 221 µmol/L) 6. Patients who have received any ERA and/or any PDE-5 inhibitor within 28 days of Baseline 7. Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of Baseline 8. Patients who have received any investigational drugs within 28 days of Baseline 9. Patients who have received CsA or tacrolimus within 28 days of Baseline 10. Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study 11. Life expectancy less than 12 months 12. Females who are lactating or pregnant (positive pre-treatment pregnancy tests (serum test at Screening and urine test on Day 1) or females who are not using a reliable method of birth control (failure rate less than 1% per year) during the study and for at least one month after study drug intake 13. Known hypersensitivity to any of the excipients of the drug formulation Day 1 Day 1 On Day 1, upon RHC, the last exclusion criteria will be checked: 14. Patients with positive response to vasoreactivity test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of a single infusion of tezosentan on Pulmonary Vascular Resistance (PVR) in patients with stable, chronic and Pulmonary Arterial Hypertension (PAH).;Secondary Objective: To evaluate the effects of a single infusion of tezosentan on hemodynamic parameters. To evaluate the safety and tolerability of a single infusion of tezosentan. ;Primary end point(s): Change in PVR from Baseline to 30 minutes expressed as percent of the Baseline value. | — |
Countries
France
Outcome results
None listed