Hypertension, Pulmonary
Conditions
Keywords
Primary or secondary Pulmonary hypertension, Iloprost, Inhaled, Long-term treatment
Brief summary
The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Interventions
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients * Secondary pulmonary hypertension * Mean pulmonary artery pressure equal or above 40 mmHg or primary pulmonary hypertension with a pressure equal or above 30 mmHg while resting during appropriate conventional treatment * Written informed consent after having been duly informed about all diagnostic and therapeutic measures involved in the study
Exclusion criteria
* Clinical Instability at baseline * Pulmonary venous obstruction * Global respiratory insufficiency * Obstructive ventilation disorders, Interstitial pulmonary disease * Cerebrovascular events * Myocardial infarction or major cardiac surgery within 3 months prior to baseline * Bleeding disorders or bleeding risk * Severe hepatic insufficiency or renal insufficiency * Malignant diseases * HIV positive * Pregnancy, female patients of child-bearing potential without adequate contraception and nursing mothers * Congenital or acquired valvular defects and myocardial function disorders not related to pulmonary hypertension * Prior pulmonary embolism * Collagenosis * Pulmonary arterial or valvular stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange | — |
| Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of long-term administration of inhaled iloprost on mortality and transplantation | — |
| Exercise capacity | — |
| Overall clinical tolerability of the long-term use of iloprost aerosol | — |
| Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange | — |
| Quality of Life | — |
| Acute effect of inhaled iloprost on hemodynamics and gas exchange | — |
| Serious Adverse Events and deaths | — |
Outcome results
None listed