check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

90570

ClinicalTrials.gov Identifier:

NCT00185315

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety follow-up study of inhaled iloprost in patients with pulmonary hypertension

Trial purpose

The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

Key Participants Requirements

Sex

Both

Age

18 - 71 Years
  • - Completion of the 12-week treatment period of the predecessor Schering study 97218/300180
    - Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient
    - Negative pregnancy test for females
  • - Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study

Trial summary

Enrollment Goal
71
Trial Dates
February 2000 - August 2005
Phase
Phase 3
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Instytut Gruzlicy i Chorob PlucWarszawa, 01138, Poland
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebrónBarcelona, 08035, Spain
Completed
CHU Reims, Hopital Robert DebreREIMS, 51092, France
Completed
Hopital Antoine BeclereClamart Cedex, 92141, France
Completed
Hopital Claude-Huriez CHRULille, 59037, France
Completed
Università di PisaPisa, 56100, Italy
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Hopital Albert CalmetteLille, 59037, France
Completed
Hopital BretonneauTours Cedex, 37044, France
Completed
Vrije Universiteit Medisch CentrumAMSTERDAM, 1081 HV, Netherlands
Completed
C.H.U. - Hopital NordGrenoble Cedex 9, 38043, France
Completed
Università di BolognaBologna, 40138, Italy
Completed
Centro Medico di MontescanoMontescano, 27040, Italy
Completed
Centro Hospitalar Vila Nova de GaiaVila Nova de Gaia, 4434-506, Portugal
Completed
Hospitais da Universidade de CoimbraCoimbra, 3000-076, Portugal
Completed
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES, 1070, Belgium

Primary Outcome

  • Adverse events
    date_rangeTime Frame:
    Throughout the whole study
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Tolerability of treatment
    date_rangeTime Frame:
    Over a minimum of 24 months
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    Safety Issue:
    None

Trial design

Open-label, uncontrolled, long-term surveillance study of iloprost aerosol inhalation therapy in the treatment of patients with primary or secondary pulmonary hypertension. Follow-up program for patients who completed 12 weeks in study ME97218/300180.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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