Tezosentan in Pulmonary Arterial Hypertension

Stopped early · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines

Key facts

Study ID

NCT01077297

Run by

Idorsia Pharmaceuticals Ltd.

People needed

3

Starts

2010-08-01

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
• Male and female patients 18 years of age or older
• 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
• Modified NYHA functional class II-III
• Documented hemodynamic diagnosis of PAH by right heart catheterization at Baseline:
• 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

You may not qualify if…

• Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
• Hypotensive patients (systemic systolic blood pressure < 100 mmHg)
• Patients with body weight < 50 kg (110 lbs)
• Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
• Patients with clinically significant chronic renal insufficiency (serum creatinine > 2.5mg/dL / 221µmol/L)
• Patients who have received any endothelin receptor antagonist (ERA) and/or any phosphodiesterase-5 (PDE-5) inhibitor within 28 days of Baseline
• Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of Baseline
• Patients who have received any investigational drugs within 28 days of Baseline
• Patients who have received cyclosporine A or tacrolimus within 28 days of Baseline
• 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 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
• Known hypersensitivity to any of the excipients of the drug formulation
• Patients with positive response to vasoreactivity test

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States
• Baylor College of Medicine — Houston, Texas, United States
• Hopital Antoine Béclère — Paris, Clamart, France
• University Hospital of Basel, Clinic of Pneumology — Basel, Switzerland
• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Switzerland

Full record on ClinicalTrials.gov

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