check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

91430

ClinicalTrials.gov Identifier:

NCT00250640

EudraCT Number:

Not Available

EU CT Number:

Not Available
Observation of patients with primary pulmonary hypertension receiving prescribed Ventavis inhalation therapy regarding safety and efficacy for up to 4 years

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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)
  • - 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)

Trial summary

Enrollment Goal
106
Trial Dates
April 2005 - July 2012
Phase
N/A
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
St. Kamillus KrankenhausMönchengladbach, 41069, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Universitätsklinikum Giessen und MarburgGießen, 35392, Germany
Completed
Deutsches HerzzentrumBerlin, 13353, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Completed
Charité Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
Klinik Löwenstein gGmbHLöwenstein, 74245, Germany
Completed
Thoraxklinik HeidelbergHeidelberg, 69126, Germany
Completed
Klinikum Innenstadt der Ludwigs-Maximilians-UniversitätMünchen, 80336, Germany
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Nouvel Hopital CIVILStrasbourg, 67091, France
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Kreisklinikum DonaueschingenDonaueschingen, 78166, Germany
Completed
Universitätsklinikum RegensburgRegensburg, 93053, Germany
Completed
Universitätsklinikum KölnKöln, 50924, Germany
Terminated
Universitätsklinikum EssenEssen, 45147, Germany
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Completed
Heliols Klinikum WuppertalWuppertal, 42283, Germany
Completed
Azienda Policlinico Umberto IRoma, 00161, Italy
Completed
Hospitais da Universidade de CoimbraCoimbra, 3000-075, Portugal
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Reina SofíaCórdoba, 14004, Spain
Terminated
Hopital Antoine BeclereClamart Cedex, 92141, France
Terminated
Hopital Claude-Huriez CHRULille, 59037, France
Terminated
Hopital Louis-PradelLyon Cedex 03, 69394, France
Terminated
Centre Hospitalier Universitaire BraboisVandoeuvre les Nancy Cedex, 54500, France
Terminated
CHU Brest La Cavale BlancheBREST, F-29609, France
Terminated
Hopital du Haut LevequePessac, 33604, France
Terminated
CHU Reims, Hopital Robert DebreREIMS, 51092, France
Terminated
Universitätskliniken des SaarlandesHomburg/Saar, 66421, Germany
Terminated
LMU Klinikum der Universität München - GroßhadernMünchen, 81377, Germany
Terminated
HELIOS Klinikum Erfurt GmbHErfurt, 99089, Germany
Terminated
Universität Erlangen-NürnbergErlangen, 91054, Germany
Terminated
Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Terminated
Istituto Fisiologia ClinicaPisa, 56100, Italy
Terminated
Policlinico San MatteoPavia, 27100, Italy
Terminated
Hospital de Santa Marta SALisboa, 1150-291, Portugal
Terminated
Glasgow Western InfirmaryGlasgow, G11 6NT, United Kingdom
Terminated
Royal Free HospitalLondon, NW3 2PF, United Kingdom
Terminated
The Royal Hallamshire HospitalSheffield, S10 2JF, United Kingdom
Terminated
Freeman HospitalNewcastle upon Tyne, NE7 7DN, United Kingdom

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Month 3 Visit
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    all scheduled visits (Study period is min. 2 years and max. 4 years)
    enhanced_encryption
    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.
    date_rangeTime Frame:
    all scheduled visits (Study period is min. 2 years and max. 4 years)
    enhanced_encryption
    Safety Issue:
    no
  • Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.
    date_rangeTime Frame:
    all scheduled visits (Study period is min. 2 years and max. 4 years)
    enhanced_encryption
    Safety Issue:
    no
  • The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.
    date_rangeTime Frame:
    all scheduled visits (Study period is min. 2 years and max. 4 years)
    enhanced_encryption
    Safety Issue:
    Yes
  • Other safety variable
    Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation
    date_rangeTime Frame:
    At all scheduled visits (Study period is min. 2 years and max. 4 years)
    enhanced_encryption
    Safety Issue:
    Yes
  • Other safety variables (optional assessment)
    Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses
    date_rangeTime Frame:
    At all scheduled visits (Study period is min. 2 years and max. 4 years)
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Open-label, uncontrolled, prospective long-term observation of Ventavis inhalation therapy in the treatment of patients with primary pulmonary hypertension up to 4 years
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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