Tezosentan in Patients With Pulmonary Arterial Hypertension

NCT01094067 | Terminated Phase 2

• 1 other identifier: AC-051-207
• Study Type: interventional
• Target: 2
• Locations: 3 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Absolute change in supine SBP from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in mmHg

  30 days

Secondary Outcomes (1)

• Absolute change in heart rate from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in bpm

  30 days

Study Arms (2)

1

EXPERIMENTAL

Placebo at visit 1, tezosentan at visit 2

Drug: ACT-050089; Other: Placebo

2

EXPERIMENTAL

Tezosentan at visit 1, placebo at visit 2

Drug: ACT-050089; Other: Placebo

Interventions

ACT-050089 DRUG

5 mg/h intravenously, Tezosentan

1; 2

Placebo OTHER

Matching placebo

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to initiation of any study-mandated procedure
• Male and female patients 18 years of age or older
• 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
• 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
• Modified NYHA functional class II-III
• 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.

You may not qualify if:

• Patients with sitting SBP \< 100 mmHg
• Patients with sitting DBP \< 60 mmHg
• Patients with body weight \< 50 kg (110 lbs)
• Patients with clinically significantly elevated liver enzymes (AST, ALT and/or alkaline phosphatase \> 3 times upper limit)
• Patients with clinically significant chronic renal insufficiency (serum creatinine \>2.5mg/dL / 221 µmol/L)
• Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
• Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost and beraprost) within 28 days of Visit 1
• Patients who have received any investigational drugs within 28 days of Visit 1
• Patients who have received cyclosporine A (CsA) or tacrolimus within 28 days of Visit 1
• 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 (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
• Known hypersensitivity to any of the excipients of the drug formulation.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (5)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Hopital Antoine Beclere

Clamart, 92141, France

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

National Cardiovascular Center

Osaka, 565-8865, Japan

Location

Keio University Hospital

Shinjuku-Ku, 160-8582, Japan

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 26, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: September 1, 2011
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

JP (3); US (1); FR (1)