Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00250640
First received: November 7, 2005
Last updated: January 12, 2014
Last verified: January 2014

November 7, 2005
January 12, 2014
April 2005
April 2012   (final data collection date for primary outcome measure)
The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline. [ Time Frame: Month 3 Visit ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00250640 on ClinicalTrials.gov Archive Site
  • Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]
  • Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]
  • Mortality, defined as all-cause mortality, will be assessed for all patients included in this study. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]
  • The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]
  • Other safety variable [ Time Frame: At all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]
    Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation
  • Other safety variables (optional assessment) [ Time Frame: At all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]
    Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses
Not Provided
Not Provided
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Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years
Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years

This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

n.a

Non-Probability Sample

Patients with the disease in scope and the prescription of Ventavis mainly from expert clinics in the participating countries

Hypertension, Pulmonary
Drug: Iloprost (Ventavis, BAYQ6256)
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet
Group 1
Intervention: Drug: Iloprost (Ventavis, BAYQ6256)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
July 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
  • Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association)
  • No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)

Exclusion Criteria:

  • Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   France,   United Kingdom,   Italy,   Portugal,   Spain
 
NCT00250640
91430, 308120
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

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