Full Text View
Tabular View
No Study Results Posted
Related Studies
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.
Study NCT00414687   Information provided by Bayer
First Received: December 20, 2006   Last Updated: May 14, 2009   History of Changes

December 20, 2006
May 14, 2009
July 1998
 
  • 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
  • Tolerability: Adverse events (AE) and safety variables
  • Acute effects of iloprost inhalation on hemodynamics and gas exchange
  • Variables to describe clinical effects:
  • NYHA class
  • Walking distance (6-min walk)
  • Mahler Dyspnea Index
  • EuroQoL
  • Borg Index
  • Karnofsky Index
  • Hemodynamic and gas exchange
  • Mortality and lung/heart-lung transplantation
Complete list of historical versions of study NCT00414687 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
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
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

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Hypertension, Pulmonary
Drug: Ventavis (Iloprost, BAYQ6256)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
63
May 2001
 

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00414687
Therapeutic Area Head, Bayer Schering Pharma AG
90427, 300341
Bayer
 
Study Director: Bayer Study Director Bayer
Bayer
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP