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
  Purpose

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.


Condition Intervention
Hypertension, Pulmonary
Drug: Iloprost (Ventavis, BAYQ6256)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Biospecimen Retention:   None Retained

n.a


Enrollment: 106
Study Start Date: April 2005
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  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: NCT00250640

  Hide Study Locations
Locations
France
Brest, France, F-29609
Clamart Cedex, France, 92141
Lille, France, 59037
Lyon Cedex 03, France, 69394
Pessac, France, 33604
Reims, France, 51092
Strasbourg, France, 67091
Vandoeuvre les Nancy Cedex, France, 54500
Germany
Donaueschingen, Baden-Württemberg, Germany, 78166
Heidelberg, Baden-Württemberg, Germany, 69120
Heidelberg, Baden-Württemberg, Germany, 69126
Löwenstein, Baden-Württemberg, Germany, 74245
Erlangen, Bayern, Germany, 91054
München, Bayern, Germany, 80336
München, Bayern, Germany, 81377
Regensburg, Bayern, Germany, 93053
Gießen, Hessen, Germany, 35392
Bonn, Nordrhein-Westfalen, Germany, 53105
Essen, Nordrhein-Westfalen, Germany, 45147
Köln, Nordrhein-Westfalen, Germany, 50924
Mönchengladbach, Nordrhein-Westfalen, Germany, 41069
Wuppertal, Nordrhein-Westfalen, Germany, 42283
Homburg/Saar, Saarland, Germany, 66421
Dresden, Sachsen, Germany, 01307
Leipzig, Sachsen, Germany, 04103
Erfurt, Thüringen, Germany, 99089
Berlin, Germany, 12200
Berlin, Germany, 13353
Hamburg, Germany, 20246
Italy
Bologna, Italy, 40138
Pavia, Italy, 27100
Pisa, Italy, 56100
Roma, Italy, 00161
Portugal
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1150-291
Spain
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Córdoba, Spain, 14004
Madrid, Spain, 28041
United Kingdom
Glasgow, United Kingdom, G11 6NT
London, United Kingdom, NW3 2PF
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00250640     History of Changes
Other Study ID Numbers: 91430, 308120
Study First Received: November 7, 2005
Last Updated: January 12, 2014
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Federal Institute for Drugs and Medical Devices
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Italy: Ethics Committee

Keywords provided by Bayer:
Primary Pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014