Tezosentan in Pulmonary Arterial Hypertension

This study has been terminated.
(Due to slow recruitment, the study was prematurely discontinued)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01077297
First received: February 25, 2010
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Tezosentan
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Change in mPAP from Baseline to 30 min [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Change in total pulmonary resistance (TPR) from Baseline to 30 min [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
  • Change in PCWP from Baseline to 30 min [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Change in cardiac output (CO) from Baseline to 30 min [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Change in cardiac index (CI) from Baseline to 30 min [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tezosentan Drug: Tezosentan
single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077297

Locations
United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
France
Hopital Antoine Béclère
Paris, Clamart, France, 92141
Switzerland
University Hospital of Basel, Clinic of Pneumology
Basel, Switzerland, CH - 4031
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Actelion
Investigators
Study Director: Elisabet Lindberg, MD Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01077297     History of Changes
Other Study ID Numbers: AC-051-206
Study First Received: February 25, 2010
Last Updated: July 13, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Tezosentan
Epoprostenol
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014