Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tezosentan in Patients With Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01094067
Recruitment Status : Terminated (Due to slow recruitment, the study was prematurely discontinued.)
First Posted : March 26, 2010
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: ACT-050089 Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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.
Study Start Date : September 1, 2010
Actual Primary Completion Date : December 1, 2010
Actual Study Completion Date : September 1, 2011


Arm Intervention/treatment
Experimental: 1
Placebo at visit 1, tezosentan at visit 2
Drug: ACT-050089
5 mg/h intravenously, Tezosentan

Other: Placebo
Matching placebo

Experimental: 2
Tezosentan at visit 1, placebo at visit 2
Drug: ACT-050089
5 mg/h intravenously, Tezosentan

Other: Placebo
Matching placebo




Primary Outcome Measures :
  1. 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 :
  1. Absolute change in heart rate from Baseline to 30 minutes at each visit (Visit 1 and Visit 2) - in bpm [ Time Frame: 30 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094067


Locations
Layout table for location information
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
France
Hopital Antoine Beclere
Clamart, France, 92141
Japan
Osaka University Hospital
Osaka, Japan, 565-0871
National Cardiovascular Center
Osaka, Japan, 565-8865
Keio University Hospital
Shinjuku-Ku, Japan, 160-8582
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.

Layout table for additonal information
Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01094067     History of Changes
Other Study ID Numbers: AC-051-207
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Endothelin Receptor Antagonists
Phosphodiesterase 5 Inhibitors
Tezosentan
Epoprostenol
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Antihypertensive Agents
Platelet Aggregation Inhibitors