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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
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00414687
First received: December 20, 2006
Last updated: May 14, 2009
Last verified: May 2009
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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
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension, Pulmonary | Drug: Ventavis (Iloprost, BAYQ6256) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Pulmonary Hypertension
Drug Information available for:
Iloprost
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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:
- 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
- Exercise capacity
- Acute effect of inhaled iloprost on hemodynamics and gas exchange
- Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
- Quality of Life
| Enrollment: | 63 |
| Study Start Date: | July 1998 |
| Study Completion Date: | May 2001 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 | Drug: Ventavis (Iloprost, BAYQ6256) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414687
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414687
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Therapeutic Area Head, Bayer Schering Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00414687 History of Changes |
| Other Study ID Numbers: |
90427 300341 |
| Study First Received: | December 20, 2006 |
| Last Updated: | May 14, 2009 |
Keywords provided by Bayer:
|
Primary or secondary Pulmonary hypertension Iloprost Inhaled Long-term treatment |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Iloprost Platelet Aggregation Inhibitors Vasodilator Agents |
ClinicalTrials.gov processed this record on September 19, 2017