Tezosentan in Patients With Pulmonary Arterial Hypertension

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.

Key facts

Study ID

NCT01094067

Run by

Idorsia Pharmaceuticals Ltd.

People needed

2

Starts

2010-09-01

Expected to finish

2011-09-01

Last updated by the study team

2018-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent prior to initiation of any study-mandated procedure
• Male and female patients 18 years of age or older
• 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
• 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
• Modified NYHA functional class II-III
• 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.

You may not qualify if…

• Patients with PAH in Dana Point Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion No. 3
• Patients with sitting SBP < 100 mmHg
• Patients with sitting DBP < 60 mmHg
• Patients with body weight < 50 kg (110 lbs)
• Patients with clinically significantly elevated liver enzymes (AST, ALT and/or alkaline phosphatase > 3 times upper limit)
• Patients with clinically significant chronic renal insufficiency (serum creatinine >2.5mg/dL / 221 µmol/L)
• Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
• Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost and beraprost) within 28 days of Visit 1
• Patients who have received any investigational drugs within 28 days of Visit 1
• Patients who have received cyclosporine A (CsA) or tacrolimus within 28 days of Visit 1
• Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study
• Life expectancy less than 12 months
• 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
• Known hypersensitivity to any of the excipients of the drug formulation.

Where it is running

• Baylor College of Medicine — Houston, Texas, United States
• Hopital Antoine Beclere — Clamart, France
• Osaka University Hospital — Osaka, Japan
• National Cardiovascular Center — Osaka, Japan
• Keio University Hospital — Shinjuku-Ku, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.