An observational study in Hypertension, Pulmonary, sponsored by Bayer. Completed at 43 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-02.
Sponsored by Bayer · Observational
This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 106 is close to the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with the disease in scope and the prescription of Ventavis mainly from expert clinics in the participating countries
Exclusion Criteria:
Drug: Iloprost (Ventavis, BAYQ6256)
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet
The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline.
Time frame: Month 3 Visit
Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL.
Time frame: all scheduled visits (Study period is min. 2 years and max. 4 years)
Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline.
Time frame: all scheduled visits (Study period is min. 2 years and max. 4 years)
Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.
Time frame: all scheduled visits (Study period is min. 2 years and max. 4 years)
The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.
Time frame: all scheduled visits (Study period is min. 2 years and max. 4 years)
Other safety variable
Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation
Time frame: At all scheduled visits (Study period is min. 2 years and max. 4 years)
Other safety variables (optional assessment)
Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses
Time frame: At all scheduled visits (Study period is min. 2 years and max. 4 years)
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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