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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations St. Kamillus Krankenhaus Mönchengladbach, Germany, 41069 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Giessen und Marburg Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Deutsches Herzzentrum Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinik Löwenstein gGmbH Löwenstein, Germany, 74245 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thoraxklinik Heidelberg Heidelberg, Germany, 69126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Innenstadt der Ludwigs-Maximilians-Universität München, Germany, 80336 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nouvel Hopital CIVIL Strasbourg, France, 67091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kreisklinikum Donaueschingen Donaueschingen, Germany, 78166 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Regensburg Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Köln Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Heliols Klinikum Wuppertal Wuppertal, Germany, 42283 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Azienda Policlinico Umberto I Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Reina Sofía Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Antoine Beclere Clamart Cedex, France, 92141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Claude-Huriez CHRU Lille, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Louis-Pradel Lyon Cedex 03, France, 69394 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire Brabois Vandoeuvre les Nancy Cedex, France, 54500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU Brest La Cavale Blanche BREST, France, F-29609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital du Haut Leveque Pessac, France, 33604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU Reims, Hopital Robert Debre REIMS, France, 51092 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätskliniken des Saarlandes Homburg/Saar, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LMU Klinikum der Universität München - Großhadern München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HELIOS Klinikum Erfurt GmbH Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universität Erlangen-Nürnberg Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istituto Fisiologia Clinica Pisa, Italy, 56100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico San Matteo Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Santa Marta SA Lisboa, Portugal, 1150-291 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Glasgow Western Infirmary Glasgow, United Kingdom, G11 6NT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Free Hospital London, United Kingdom, NW3 2PF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Royal Hallamshire Hospital Sheffield, United Kingdom, S10 2JF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Freeman Hospital Newcastle upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
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.Timeframe: Month 3 Visit
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.Timeframe: all scheduled visits (Study period is min. 2 years and max. 4 years)
- 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.Timeframe: all scheduled visits (Study period is min. 2 years and max. 4 years)
- Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.Timeframe: all scheduled visits (Study period is min. 2 years and max. 4 years)
- The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.Timeframe: all scheduled visits (Study period is min. 2 years and max. 4 years)
- Other safety variableWeight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantationTimeframe: At all scheduled visits (Study period is min. 2 years and max. 4 years)
- Other safety variables (optional assessment)Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analysesTimeframe: At all scheduled visits (Study period is min. 2 years and max. 4 years)
Additional Information
Copyright © Bayer
Powered by
