Tezosentan in Pulmonary Arterial Hypertension

NCT ID: NCT01077297

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-09-30

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

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tezosentan

Group Type: EXPERIMENTAL

Tezosentan

Intervention Type: DRUG

single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg

Interventions

Tezosentan

single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabet Lindberg, MD

Role: STUDY_DIRECTOR

Actelion

Locations

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

Countries

United States; France; Switzerland

Other Identifiers

AC-051-206

Identifier Type: -

Identifier Source: org_study_id