Trial Condition(s):

Hypertension, Pulmonary

Observation of patients with primary pulmonary hypertension receiving prescribed Ventavis inhalation therapy regarding safety and efficacy for up to 4 years

Bayer Identifier:

91430

ClinicalTrials.gov Identifier:

NCT00250640

EudraCT Number:

Not Available

Study Completed

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.

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)

Trial Summary

Enrollment Goal
106
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

St. Kamillus Krankenhaus

Mönchengladbach, Germany, 41069

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Universitätsklinikum Giessen und Marburg

Gießen, Germany, 35392

Status
Completed
 
Locations

Deutsches Herzzentrum

Berlin, Germany, 13353

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

Klinik Löwenstein gGmbH

Löwenstein, Germany, 74245

Status
Completed
 
Locations

Thoraxklinik Heidelberg

Heidelberg, Germany, 69126

Status
Completed
 
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Nouvel Hopital CIVIL

Strasbourg, France, 67091

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Kreisklinikum Donaueschingen

Donaueschingen, Germany, 78166

Status
Completed
 
Locations

Universitätsklinikum Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50924

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45147

Status
Terminated
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Completed
 
Locations

Heliols Klinikum Wuppertal

Wuppertal, Germany, 42283

Status
Completed
 
Locations

Azienda Policlinico Umberto I

Roma, Italy, 00161

Status
Completed
 
Locations

Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3000-075

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital Reina Sofía

Córdoba, Spain, 14004

Status
Completed
 
Locations

Hopital Antoine Beclere

Clamart Cedex, France, 92141

Status
Terminated
 
Locations

Hopital Claude-Huriez CHRU

Lille, France, 59037

Status
Terminated
 
Locations

Hopital Louis-Pradel

Lyon Cedex 03, France, 69394

Status
Terminated
 
Locations

Centre Hospitalier Universitaire Brabois

Vandoeuvre les Nancy Cedex, France, 54500

Status
Terminated
 
Locations

CHU Brest La Cavale Blanche

BREST, France, F-29609

Status
Terminated
 
Locations

Hopital du Haut Leveque

Pessac, France, 33604

Status
Terminated
 
Locations

CHU Reims, Hopital Robert Debre

REIMS, France, 51092

Status
Terminated
 
Locations

Universitätskliniken des Saarlandes

Homburg/Saar, Germany, 66421

Status
Terminated
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Terminated
 
Locations

HELIOS Klinikum Erfurt GmbH

Erfurt, Germany, 99089

Status
Terminated
 
Locations

Universität Erlangen-Nürnberg

Erlangen, Germany, 91054

Status
Terminated
 
Locations

Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Status
Terminated
 
Locations

Istituto Fisiologia Clinica

Pisa, Italy, 56100

Status
Terminated
 
Locations

Policlinico San Matteo

Pavia, Italy, 27100

Status
Terminated
 
Locations

Hospital de Santa Marta SA

Lisboa, Portugal, 1150-291

Status
Terminated
 
Locations

Glasgow Western Infirmary

Glasgow, United Kingdom, G11 6NT

Status
Terminated
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2PF

Status
Terminated
 
Locations

The Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Status
Terminated
 
Locations

Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE7 7DN

Status
Terminated
 

Trial Design