Tezosentan in Patients With Pulmonary Arterial Hypertension

NCT ID: NCT01094067

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-01
• Study Completion Date: 2011-09-01

Brief Summary

Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo at visit 1, tezosentan at visit 2

Group Type: EXPERIMENTAL

ACT-050089

Intervention Type: DRUG

5 mg/h intravenously, Tezosentan

Placebo

Intervention Type: OTHER

Matching placebo

2

Tezosentan at visit 1, placebo at visit 2

Group Type: EXPERIMENTAL

ACT-050089

Intervention Type: DRUG

5 mg/h intravenously, Tezosentan

Placebo

Intervention Type: OTHER

Matching placebo

Interventions

ACT-050089

5 mg/h intravenously, Tezosentan

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent prior to initiation of any study-mandated procedure

2. Male and female patients 18 years of age or older

3. Patients with PAH according to one of the following subgroups of the Dana Point Classification Group 1:

• Idiopathic, or
• Heritable, or
• Associated with connective tissue disease

4. Documented hemodynamic diagnosis of PAH by right heart catheterization (not part of study mandated procedures):

• Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
• Resting mean pulmonary vascular resistance (PVR) ≥ 240 dyn•s•cm 5 and
• Pulmonary capillary wedge pressure ≤ 15 mmHg

5. Modified NYHA functional class II-III

6. Patients on treatment with ERAs, PDE-5 inhibitors or a combination of both, if used for at least 3 months prior to Visit 1 and dosing kept stable for at least 28 days prior to Visit 1.

Exclusion Criteria

1. Patients with PAH in Dana Point Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion No. 3

2. Patients with sitting SBP < 100 mmHg

3. Patients with sitting DBP < 60 mmHg

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

5. Patients with clinically significantly elevated liver enzymes (AST, ALT and/or alkaline phosphatase > 3 times upper limit)

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

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

8. Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost and beraprost) within 28 days of Visit 1

9. Patients who have received any investigational drugs within 28 days of Visit 1

10. Patients who have received cyclosporine A (CsA) or tacrolimus within 28 days of Visit 1

11. Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study

12. Life expectancy less than 12 months

13. Females who are lactating or pregnant (positive pre-treatment pregnancy tests) (serum test at Screening and urine test on Visit 1 and 2) 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 last administration of study drug

14. Known hypersensitivity to any of the excipients of the drug formulation.

• 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

Locations

Baylor College of Medicine

Houston, Texas, United States

Hopital Antoine Beclere

Clamart, , France

Osaka University Hospital

Osaka, , Japan

National Cardiovascular Center

Osaka, , Japan

Keio University Hospital

Shinjuku-Ku, , Japan

Countries

United States; France; Japan

Other Identifiers

AC-051-207

Identifier Type: -

Identifier Source: org_study_id