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Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185315
First received: September 13, 2005
Last updated: April 19, 2010
Last verified: April 2010
History of Changes
  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.


Condition Intervention Phase
Hypertension, Pulmonary
 Drug: Ventavis (Iloprost, BAYQ6256)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Drug Information available for: Iloprost
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Throughout the whole study ]

Secondary Outcome Measures:
  • Tolerability of treatment [ Time Frame: Over a minimum of 24 months ]

Enrollment: 71
Study Start Date: February 2000
Study Completion Date: August 2005
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ventavis (Iloprost, BAYQ6256)
Inhaled iloprost

Detailed Description:

This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

  Eligibility

Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185315

Locations
Belgium
Bruxelles, Belgium, 1070
Leuven, Belgium, 3000
France
Clamart Cedex, France, 92141
Grenoble Cedex 9, France, 38043
Lille, France, 59037
Reims, France, 51092
Tours Cedex, France, 37044
Italy
Bologna, BO, Italy, 40138
Montescano, Pavia, Italy, 27040
Pisa, PI, Italy, 56100
Netherlands
Amsterdam, Netherlands, 1081 HV
Poland
Warszawa, Poland, 01138
Portugal
Coimbra, Portugal, 3000-076
Vila Nova de Gaia, Portugal, 4434-506
Spain
Barcelona, Spain, 08035
Madrid, Spain, 28041
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185315     History of Changes
Other Study ID Numbers: 90570, 303045, Follow-up 90419-300180
Study First Received: September 13, 2005
Last Updated: April 19, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health and Consumption
Portugal: National Pharmacy and Medicines Institute
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

ClinicalTrials.gov processed this record on May 22, 2013