Pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension
Conditions
Sponsors
Ergonex Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male patients of any racial origin with PAH (WHO classification II-IV) 2. On stable treatment with best supportive care with anticoagulant drugs, diuretics, cardiac glycosides, supplemental oxygen and calcium channels blockers, adjusted to the individual need of the respective patient. Specific PAH mono-therapy (or combination-therapy not exceeding two PAH specific drugs) with either endothelin receptor antagonists or phosphodiesterase type 5 inhibitors or non-parenteral prostanoids (i.e. inhaled, oral, s.c.) is allowed (pre-treated patients) but not mandatory (treatment naive patients). Patients already on PAH specific drugs must be receiving a stable dose of the medication for at least 3 months 3. Having fulfilled his/her 18th birthday on Day 1 of the study but not older than 80 years (up to the patient’s 81st birthday). 4. PAH due to idiopathic pulmonary arterial hypertension or connective tissue disease associated PAH 5. Cardiac catheterisation 4 weeks prior to screening or at screening with PAH, specifically PAPm >=25 mmHg (at rest), Pulmonary capillary wedge pressure (PCWP) =500 dyn x sec x cm-5. Echocardiogram at screening consistent with PAH, specifically evidence of right ventricular hypertrophy or dilation, evidence of normal left ventricular function, and absence of mitral valve stenosis 6. Six minute walk distance above 150 m 7. Receiving conventional PAH therapy, stable for one month. 8. Presentation of negative test results in regard to HIV, Hepatitis C/B, not older than 4 weeks. 9. Able to understand and willing to sign the Informed Consent Form. 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
Exclusion criteria: 1. Pregnancy and/or lactation 2. PAH of any cause other than permitted in the entry criteria 3. Contraindication for heart catheterisation 4. Any change in disease-targeted therapy within the last month before screening 5. Patients requiring intravenous prostanoid therapy within 3 months prior to study start 6. Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study 7. Known intolerance to Terguride 8. Active liver disease, porphyria or elevations of serums transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN 9. History or suspicion of inability to cooperate adequately . 10. Cancer or other malign haematological disease 11. Pulmonary Hypertension caused by left heart disease 12. Pulmonary Arterial Hypertension associated with congenital heart disease (PAH-CHD) 13. Pulmonary Arterial Hypertension associated with human immunodeficiency virus infection (PAH-HIV) 14. Portopulmonary Hypertension (PPHT) 15. CTEPH Chronic Thromboembolic Pulmonary Hypertension 16. Pulmonary Hypertension associated with other diseases (i.e. Sarcoidosis, Histiocytosis, etc) 17. Pulmonary Hypertension associated with other chronic lung diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: To assess efficacy on pulmonary artery pressure after 15 weeks of therapy compared to baseline by comparison of the pulmonary vascular resistance. ;Secondary Objective: The secondary objective of the study is: To assess clinical, haemodynamic, respiratory, functional and cardiovascular parameters following treatment with Terguride (dosage between 1,5 mg/day min and 3,0 mg/day max) after 15 weeks To assess efficacy and tolerability of Terguride in the treatment of patients with PAH compared to placebo for 15 weeks. To assess safety of Terguride in comparison to placebo over a period of time of 15 weeks. ;Primary end point(s): Primary endpoint for this investigation is: Pulmonary vascular resistance at final cardiac catheterisation (15 weeks from initial cardiac catheterisation) as objective measure Benchmark: significant reduction (20% vs. baseline) of pulmonary vascular resistance | — |
Countries
Austria, Czech Republic, Germany, Netherlands
Outcome results
None listed