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Tezosentan in Patients With Pulmonary Arterial Hypertension

This study has been terminated.
(Due to slow recruitment, the study was prematurely discontinued.)
Information provided by (Responsible Party):
Actelion Identifier:
First received: March 25, 2010
Last updated: July 13, 2012
Last verified: July 2012
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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 ]

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 ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01094067

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

Responsible Party: Actelion Identifier: NCT01094067     History of Changes
Other Study ID Numbers: AC-051-207
Study First Received: March 25, 2010
Last Updated: July 13, 2012

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Endothelin Receptor Antagonists
Phosphodiesterase 5 Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Antihypertensive Agents
Platelet Aggregation Inhibitors processed this record on June 23, 2017