Tezosentan in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01077297
• Other study ID #: AC-051-206
• Status: Terminated
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent

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

5. 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:

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 < 100 mmHg)

3. Patients with body weight < 50 kg (110 lbs)

4. Patients with moderate or severe hepatic impairment (Child-Pugh B and C)

5. Patients with clinically significant chronic renal insufficiency (serum creatinine > 2.5mg/dL / 221µmol/L)

6. Patients who have received any endothelin receptor antagonist (ERA) and/or any phosphodiesterase-5 (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 cyclosporine A 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 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

14. Patients with positive response to vasoreactivity test

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Tezosentan
single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.		30 minutes
Secondary	Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes		30 minutes
Secondary	Change in mPAP from Baseline to 30 min		30 minutes
Secondary	Change in total pulmonary resistance (TPR) from Baseline to 30 min		30 minutes
Secondary	Change in PCWP from Baseline to 30 min		30 minutes
Secondary	Change in cardiac output (CO) from Baseline to 30 min		30 minutes
Secondary	Change in cardiac index (CI) from Baseline to 30 min		30 minutes