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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: EUCTR
Last refreshed on: 4 April 2022
Main ID:  EUCTR2009-012450-20-FR
Date of registration: 07/09/2009
Prospective Registration: Yes
Primary sponsor: Actelion Pharmaceuticals Ltd.
Public 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
Scientific 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
Date of first enrolment: 15/10/2009
Target sample size: 13
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012450-20
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
France
Contacts
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Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Pulmonary arterial hypertension
MedDRA version: 12.0 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
Intervention(s)

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-

Primary Outcome(s)
Primary end point(s): Change in PVR from Baseline to 30 minutes expressed as percent of the Baseline value.
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.
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).
Secondary Outcome(s)
Secondary ID(s)
AC-051-206
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 15/10/2009
Contact:
Results
Results available: Yes
Date Posted: 31/12/2016
Date Completed: 10/05/2011
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-012450-20/results
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