Back to resultsTezosentan in Pulmonary Arterial Hypertension
Primary Purpose
Pulmonary Arterial Hypertension
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tezosentan
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
- 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
Sites / Locations
- Washington University School of Medicine
- Baylor College of Medicine
- Hopital Antoine Béclère
- University Hospital of Basel, Clinic of Pneumology
- Centre Hospitalier Universitaire Vaudois (CHUV)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tezosentan
Arm Description
Outcomes
Primary Outcome Measures
Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.
Secondary Outcome Measures
Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes
Change in mPAP from Baseline to 30 min
Change in total pulmonary resistance (TPR) from Baseline to 30 min
Change in PCWP from Baseline to 30 min
Change in cardiac output (CO) from Baseline to 30 min
Change in cardiac index (CI) from Baseline to 30 min
Full Information
NCT ID
NCT01077297
First Posted
February 25, 2010
Last Updated
July 6, 2018
Sponsor
Idorsia Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01077297
Brief Title
Tezosentan in Pulmonary Arterial Hypertension
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Due to slow recruitment, the study was prematurely discontinued
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tezosentan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tezosentan
Intervention Description
single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg
Primary Outcome Measure Information:
Title
Change in PVR from Baseline to 30 minutes expresses as percent of the Baseline value.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Change in mean right arterial pressure (mRAP) from Baseline to 30 minutes
Time Frame
30 minutes
Title
Change in mPAP from Baseline to 30 min
Time Frame
30 minutes
Title
Change in total pulmonary resistance (TPR) from Baseline to 30 min
Time Frame
30 minutes
Title
Change in PCWP from Baseline to 30 min
Time Frame
30 minutes
Title
Change in cardiac output (CO) from Baseline to 30 min
Time Frame
30 minutes
Title
Change in cardiac index (CI) from Baseline to 30 min
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients with PAH in Venice Classification Groups 2-5, and PAH Group 1 subgroups not covered by inclusion criterion no. 3
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabet Lindberg, MD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hopital Antoine Béclère
City
Paris
State/Province
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
University Hospital of Basel, Clinic of Pneumology
City
Basel
ZIP/Postal Code
CH - 4031
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
12. IPD Sharing Statement
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Tezosentan in Pulmonary Arterial Hypertension
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