Tezosentan in Pulmonary Arterial Hypertension
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tezosentan
|
Drug: Tezosentan
single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg
|
Outcome Measures
Primary Outcome Measures
- Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value. [30 minutes]
Secondary Outcome Measures
- Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes [30 minutes]
- Change in mPAP from Baseline to 30 min [30 minutes]
- Change in total pulmonary resistance (TPR) from Baseline to 30 min [30 minutes]
- Change in PCWP from Baseline to 30 min [30 minutes]
- Change in cardiac output (CO) from Baseline to 30 min [30 minutes]
- Change in cardiac index (CI) from Baseline to 30 min [30 minutes]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 2 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 3 | Hopital Antoine Béclère | Paris | Clamart | France | 92141 |
| 4 | University Hospital of Basel, Clinic of Pneumology | Basel | Switzerland | CH - 4031 | |
| 5 | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Switzerland | CH-1011 |
Sponsors and Collaborators
- Idorsia Pharmaceuticals Ltd.
Investigators
- Study Director: Elisabet Lindberg, MD, Actelion
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AC-051-206