Tezosentan in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01077297
• Date of registration: 25/02/2010
• Prospective Registration: Yes
• Primary sponsor: Idorsia Pharmaceuticals Ltd.
• Public title: Tezosentan in Pulmonary Arterial Hypertension
• Scientific 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
• Date of first enrolment: August 2010
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01077297
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France, Switzerland, United States

Contacts

• Name: Elisabet Lindberg, MD
• Affiliation: Actelion

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Tezosentan

Primary Outcome(s)

Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value. [Time Frame: 30 minutes]

Secondary Outcome(s)

Change in PCWP from Baseline to 30 min [Time Frame: 30 minutes]

Change in cardiac output (CO) from Baseline to 30 min [Time Frame: 30 minutes]

Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes [Time Frame: 30 minutes]

Change in cardiac index (CI) from Baseline to 30 min [Time Frame: 30 minutes]

Change in mPAP from Baseline to 30 min [Time Frame: 30 minutes]

Change in total pulmonary resistance (TPR) from Baseline to 30 min [Time Frame: 30 minutes]

Secondary ID(s)

AC-051-206

Source(s) of Monetary Support

Please refer to primary and secondary sponsors