- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00414687
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
May 14, 2009 updated by: Bayer
An Explorative, Open-Label, Multicenter, Randomized, Parallel-Group Comparative Study of Safety, Tolerability, and the Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension Over 2 Years
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome Measure |
---|
Quality of Life
|
Exercise capacity
|
Overall clinical tolerability of the long-term use of iloprost aerosol
|
Serious Adverse Events and deaths
|
Effect of long-term administration of inhaled iloprost on mortality and transplantation
|
Acute effect of inhaled iloprost on hemodynamics and gas exchange
|
Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1998
Study Completion (Actual)
May 1, 2001
Study Registration Dates
First Submitted
December 20, 2006
First Submitted That Met QC Criteria
December 20, 2006
First Posted (Estimate)
December 21, 2006
Study Record Updates
Last Update Posted (Estimate)
May 15, 2009
Last Update Submitted That Met QC Criteria
May 14, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90427
- 300341
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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