Tezosentan in Pulmonary Arterial Hypertension

NCT01077297 | Terminated Phase 2

• 1 other identifier: AC-051-206
• Study Type: interventional
• Target: 3
• Locations: 3 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.

  30 minutes

Secondary Outcomes (6)

• Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes

  30 minutes

• Change in mPAP from Baseline to 30 min

  30 minutes

• Change in total pulmonary resistance (TPR) from Baseline to 30 min

  30 minutes

• Change in PCWP from Baseline to 30 min

  30 minutes

• Change in cardiac output (CO) from Baseline to 30 min

  30 minutes

Study Arms (1)

Tezosentan

EXPERIMENTAL

Drug: Tezosentan

Interventions

Tezosentan DRUG

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

Tezosentan

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
• Male and female patients 18 years of age or older
• 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
• Modified NYHA functional class II-III
• 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

You may not qualify if:

• Hypotensive patients (systemic systolic blood pressure \< 100 mmHg)
• Patients with body weight \< 50 kg (110 lbs)
• Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
• Patients with clinically significant chronic renal insufficiency (serum creatinine \> 2.5mg/dL / 221µmol/L)
• Patients who have received any endothelin receptor antagonist (ERA) and/or any phosphodiesterase-5 (PDE-5) inhibitor within 28 days of Baseline
• Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost) within 28 days of Baseline
• Patients who have received any investigational drugs within 28 days of Baseline
• Patients who have received cyclosporine A or tacrolimus within 28 days of Baseline
• 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 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
• Known hypersensitivity to any of the excipients of the drug formulation
• Patients with positive response to vasoreactivity test

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (5)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Hopital Antoine Béclère

Paris, Clamart, 92141, France

Location

University Hospital of Basel, Clinic of Pneumology

Basel, CH - 4031, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, CH-1011, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

tezosentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elisabet Lindberg, MD

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2018-07

Locations

CH (2); FR (1); US (2)