None listed
Conditions
Interventions
Trade Name: Certican
Product Name: Certican
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351696
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients with pulmonary arterial or thromboembolic pulmonary - Age: 18 – 65 years - ongoing vaso dilative therapy with at least two medications approved for the treatment of pulmonary arterial hypertension for at least six months (no dose adjustments over the past three months) - steady or progressive pulmonary hypertension associated with at least two of the following parameters associated with a poor prognosis: *Cardiac index = 2,1 l/min/m2 *6 MWD = 380 m *systolic RR = 120 mmHg *VO2max = 11 l/min/kg *SVO2 = 60% *Hf = 90/min *probabilty for survival of one year = 0,7 following the NIH formular - written declaration of consent of the patient 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - decompensated right ventricular cardiac insufficiency associated with an indication for transplantation or intravenous Iloprost-therapy (a stable, established therapy regimen with intravenous Iloprost does not represent an exclusion criterium) - postcapillary pulmonary hypertension (wedge pressure > 11 mmHg) - liver cirrhosis CHILD Pugh B und C - liver insufficiency - Transaminases > 3 times hogher than normal - known hypersensitivity to Everolimus or other ingredients of the IMP - expected low compliance - pregnant or lactating women - women with childbearing capacity not using a highly effective method of birth control, defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. - participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is the improvement of hemodynamic parameters and functional capability of pulmonary hypertension patients.;Secondary Objective: The secondary objective of the CT is to assess the safety and tolerance of Certican (Everolimus) in the treatment of pulmonary hypertension patients.;Primary end point(s): improvement concerning the distance in the 6 MWT, decrease of pulomary ventricular pressure | — |
Countries
Germany
Outcome results
None listed