check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:
90427
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Aerosolized Randomized Iloprost Study II (AIR - II) Long-term safety, tolerability, and clinical effects of iloprost inhalation in patients with primary or secondary pulmonary hypertension
Trial purpose
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
Key Participants Requirements
Sex
BothAge
18 - 70 YearsTrial summary
Enrollment Goal
63Trial Dates
July 1998 - May 2001Phase
Phase 2Could I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoPrimary Outcome
- 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 exchangeenhanced_encryptionNoneSafety Issue:
- Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchangeenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Overall clinical tolerability of the long-term use of iloprost aerosolenhanced_encryptionNoneSafety Issue:
- Serious Adverse Events and deathsenhanced_encryptionNoneSafety Issue:
- Effect of long-term administration of inhaled iloprost on mortality and transplantationenhanced_encryptionNoneSafety Issue:
- Exercise capacityenhanced_encryptionNoneSafety Issue:
- Acute effect of inhaled iloprost on hemodynamics and gas exchangeenhanced_encryptionNoneSafety Issue:
- Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchangeenhanced_encryptionNoneSafety Issue:
- Quality of Lifeenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
1