Tezosentan in Patients With 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:
NCT01094067
First received: March 25, 2010
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: ACT-050089
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Multi-center, 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.

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Absolute change in supine SBP from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in mmHg [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in heart rate from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in bpm [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Placebo at visit 1, tezosentan at visit 2
Drug: ACT-050089
5 mg/h intravenously
Other Name: Tezosentan or matching placebo
Experimental: 2
Tezosentan at visit 1, placebo at visit 2
Drug: ACT-050089
5 mg/h intravenously
Other Name: Tezosentan or matching placebo

  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 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
  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: NCT01094067

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
France
Hopital Antoine Beclere
Clamart, France, 92141
Japan
Keio University Hospital
Shinjjyuku-ku, Tokyo, Japan, 160-8582
National Cardiovascular Center
Suita, Osaka, Japan, 565-8865
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01094067     History of Changes
Other Study ID Numbers: AC-051-207
Study First Received: March 25, 2010
Last Updated: July 13, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
European Union: European Medicines Agency
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on September 18, 2014