Multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of tezosentan in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing cardiac surgery - ND
- Conditions
- Separation from cardiopulmonary by-passMedDRA version: 9.1Level: LLTClassification code 10039163Term: Right ventricular failure
- Registration Number
- EUCTR2006-002907-15-IT
- Lead Sponsor
- Actelion Pharmaceuticals LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
1) Patients ? 18 years of age 2) Male or female patients (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception) 3) Patients undergoing complex cardiac surgery on CPB and having sPAP > 40 mmHg or mPAP > 30 mmHg (measured at screening by RHC or echocardiography) or patients undergoing cardiac surgery on CPB and having pre-operative pulmonary hypertension due to left heart disease (measured at screening by RHC or echocardiography) defined as sPAP > 60 mmHg with mPAP/MAP > 0.5 or sPAP > 60 mmHg with signs and/or symptoms of right ventricular dysfunction 4) Signed informed consent prior to any study-mandated procedure.
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
1) Sitting systolic blood pressure < 100 mmHg (measured at hospital admission) 2) Significant chronic lung disease that might interfere with the ability to interpret the study results (e.g., severe chronic obstructive pulmonary disease).3) Emergency surgery 4) Pregnant or breast-feeding females 5) Use of another investigational drug within 28 days prior to randomization 6) Complex adult congenital heart disease 7) Severe concomitant illness limiting life expectancy (< 6 months) 8) Participation in a device study that will affect the outcome of the study 9) Pre-operative use of balloon pump 10) Pre-operative use of inotropes/vasopressor drugs 11) Pre-operative treatment of pulmonary arterial hypertension (PAH) 12) Known hypersensitivity to tezosentan or drugs of the same class, or any of their excipients 13) Severe liver impairement
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method