Tezosentan in Patients With Pulmonary Arterial Hypertension

Launched by IDORSIA PHARMACEUTICALS LTD. · Mar 25, 2010

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • 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 Dana Point Classification Group 1:
• • Idiopathic, or
• • Heritable, or
• • Associated with connective tissue disease
• 4. Documented hemodynamic diagnosis of PAH by right heart catheterization (not part of study mandated procedures):
• • Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
• • Resting mean pulmonary vascular resistance (PVR) ≥ 240 dyn•s•cm 5 and
• • Pulmonary capillary wedge pressure ≤ 15 mmHg
• • 5. Modified NYHA functional class II-III
• • 6. Patients on treatment with ERAs, PDE-5 inhibitors or a combination of both, if used for at least 3 months prior to Visit 1 and dosing kept stable for at least 28 days prior to Visit 1.
• Exclusion Criteria :
• • 1. Patients with PAH in Dana Point Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion No. 3
• • 2. Patients with sitting SBP \< 100 mmHg
• • 3. Patients with sitting DBP \< 60 mmHg
• • 4. Patients with body weight \< 50 kg (110 lbs)
• • 5. Patients with clinically significantly elevated liver enzymes (AST, ALT and/or alkaline phosphatase \> 3 times upper limit)
• • 6. Patients with clinically significant chronic renal insufficiency (serum creatinine \>2.5mg/dL / 221 µmol/L)
• • 7. Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
• • 8. Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost and beraprost) within 28 days of Visit 1
• • 9. Patients who have received any investigational drugs within 28 days of Visit 1
• • 10. Patients who have received cyclosporine A (CsA) or tacrolimus within 28 days of Visit 1
• • 11. Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study
• • 12. Life expectancy less than 12 months
• • 13. Females who are lactating or pregnant (positive pre-treatment pregnancy tests) (serum test at Screening and urine test on Visit 1 and 2) 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 last administration of study drug
• • 14. Known hypersensitivity to any of the excipients of the drug formulation.