NL-OMON31244WithdrawnPhase 3
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 - Tezosentan in patients with pre-operative PH undergoing cardiac surgery.
Actelion Pharmaceuticals0 sites10 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Male or female patients >=18 years of age (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception).
- •- Patients undergoing complex* cardiac surgery on CPB and having sPAP > 40 mmHg or mPAP > 30 mmHg (measured by RHC or echocardiography at screening). * Complex cardiac surgery is defined as:
- •- Surgery on two valves
- •- Surgery on one valve plus revascularization
- •- Re-operation of previous valve surgery. ;Or ;Patients undergoing cardiac surgery on CPB and having pre-operative pulmonary hypertension due to left heart disease (measured by RHC or echocardiography at screening) defined as:
- •- sPAP > 60 mmHg with mPAP/MAP > 0.5
- •- sPAP > 60 mmHg with signs and/or symptoms of right ventricular dysfunction.
- •- Signed informed consent prior to any study-mandated procedure. ;(MAP = mean arterial pressure; mPAP = mean pulmonary arterial pressure; sPAP = systolic pulmonary arterial pressure; RHC = right heart catheterization.)
Exclusion Criteria
- •- Sitting systolic blood pressure < 100 mmHg (measured at hospital admission).
- •- Significant chronic lung disease that might interfere with the ability to interpret the study results (e.g., severe chronic obstructive pulmonary disease).
- •- Emergency surgery.
- •- Pregnant or breast-feeding females.
- •- Use of another investigational drug within 28 days prior to randomization.
- •- Complex adult congenital heart disease.
- •- Severe concomitant illness limiting life expectancy (< 6 months).
- •- Participation in a device study that will affect the outcome of the study.
- •- Pre-operative use of balloon pump.
- •- Pre-operative use of inotropes/vasopressor drugs.
- •- Pre-operative treatment of pulmonary arterial hypertension (PAH).
- •- Known hypersensitivity to tezosentan or drugs of the same class, or any of their excipients.
- •- Severe liver impairment.
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