E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
- steady or progressive pulmonary hypertension accompanied by 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 of survival for one year ≤ 0,7 following the NIH-formular |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037400 |
E.1.2 | Term | Pulmonary hypertension |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is the improvement of hemodynamic parameters and functional capability of pulmonary hypertension patients. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the CT is to assess the safety and tolerance of Certican (Everolimus) in the treatment of pulmonary hypertension patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
improvement concerning the distance in the 6 MWT, decrease of pulomary ventricular pressure |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |