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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00414687
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : May 15, 2009
Sponsor:
Information provided by:
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: Ventavis (Iloprost, BAYQ6256) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
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
Study Start Date : July 1998
Actual Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Ventavis (Iloprost, BAYQ6256)


Outcome Measures
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Primary Outcome Measures :
  1. 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
  2. Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange

Secondary Outcome Measures :
  1. Overall clinical tolerability of the long-term use of iloprost aerosol
  2. Serious Adverse Events and deaths
  3. Effect of long-term administration of inhaled iloprost on mortality and transplantation
  4. Exercise capacity
  5. Acute effect of inhaled iloprost on hemodynamics and gas exchange
  6. Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
  7. Quality of Life

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414687


Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00414687    
Other Study ID Numbers: 90427
300341
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009
Keywords provided by Bayer:
Primary or secondary Pulmonary hypertension
Iloprost
Inhaled
Long-term treatment
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents