check_circleStudy Completed
pulmonary arterial hypertension
Bayer Identifier:
16483
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Comparative PK PD Study in PAH patients (Fox vs. I-Neb)
Trial purpose
Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
27Trial Dates
March 2014 - September 2017Phase
Phase 1/Phase 2Could I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Gießen, 35392, Germany | |
Completed | Hamburg, 20246, Germany | |
Completed | Köln, 50924, Germany | |
Completed | Würzburg, 97067, Germany | |
Completed | München, 80639, Germany | |
Completed | Graz, 8036, Austria |
Primary Outcome
- The proportion of patients with a meaningful maximum increase (i.e. >=25%) in heart rate AND/OR a meaningful maximum decrease (i.e. >=20%) in systolic blood pressure within the 30 minutes after the start of inhalationdate_rangeTime Frame:multiple measurements within 30 minutes after iloprost inhalationenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Maximum change in systolic, diastolic and mean arterial blood pressuredate_rangeTime Frame:From baseline to multiple BP measurements within 2 hours after iloprost inhalationenhanced_encryptionYesSafety Issue:
- Maximum change in heart rate within the 30 minutes following inhalationdate_rangeTime Frame:From baseline to multiple HR measurements within 30 minutes after iloprost inhalationenhanced_encryptionYesSafety Issue:
- Maximum change in oxygen saturation within the 30 minutes following inhalation using finger pulse oxymetrydate_rangeTime Frame:From baseline to multiple measurements within 30 minutes after iloprost inhalationenhanced_encryptionYesSafety Issue:
- AUC (area under the plasma concentration curve of BAYQ6256 from zero to infinity)date_rangeTime Frame:Multiple timepoints up to 1 hourenhanced_encryptionNoSafety Issue:
- Maximum observed drug concentration in plasma after single dose administrationdate_rangeTime Frame:Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalyticsenhanced_encryptionNoSafety Issue:
- Time to reach maximum drug observed concentration in plasma after single dosedate_rangeTime Frame:Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalyticsenhanced_encryptionNoSafety Issue:
- half-life (associated with terminal slope)date_rangeTime Frame:Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalyticsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2