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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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4 April 2022 |
Main ID: |
EUCTR2009-012450-20-FR |
Date of registration:
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07/09/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
Date of first enrolment:
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15/10/2009 |
Target sample size:
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13 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012450-20 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion criteria: Screening 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 Venice Classification Group 1: · Idiopathic (iPAH), or · Familial / heritable (FPAH), or · Associated (APAH) with collagen vascular disease 4. Modified NYHA functional class II-III
Day 1 On Day 1, upon right heart catheterization (RHC), the last inclusion criteria will be checked: 5. Documented hemodynamic diagnosis of PAH by right heart catheterization on Day 1: · 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
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Screening 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 / 221 µmol/L) 6. Patients who have received any ERA and/or any 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 CsA 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 (positive pre-treatment pregnancy tests (serum test at Screening and urine test on Day 1) 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 Day 1
Day 1 On Day 1, upon RHC, the last exclusion criteria will be checked: 14. Patients with positive response to vasoreactivity test
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Pulmonary arterial hypertension MedDRA version: 12.0
Level: LLT
Classification code 10064911
Term: Pulmonary arterial hypertension
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Intervention(s)
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Product Name: Tezosentan Product Code: ACT-050089 (Ro 61-0612) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tezosentan CAS Number: 180384-58-0 Current Sponsor code: ACT-050089 (Ro 61-0612) Other descriptive name: Tezosentan Concentration unit: % (V/V) percent volume/volume Concentration type: equal Concentration number: 1-
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Primary Outcome(s)
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Primary end point(s): Change in PVR from Baseline to 30 minutes expressed as percent of the Baseline value.
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Secondary Objective: To evaluate the effects of a single infusion of tezosentan on hemodynamic parameters. To evaluate the safety and tolerability of a single infusion of tezosentan.
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Main Objective: To evaluate the effect of a single infusion of tezosentan on Pulmonary Vascular Resistance (PVR) in patients with stable, chronic and Pulmonary Arterial Hypertension (PAH).
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Secondary ID(s)
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AC-051-206
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 15/10/2009
Contact:
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