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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185315

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
Pulmonary Hypertension	Drug: Inhaled iloprost	Phase III

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Iloprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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.

Further study details as provided by Bayer:

Primary Outcome Measures:

Adverse events

Secondary Outcome Measures:

Tolerability of treatment over a minimum of 24 months

Study Start Date:

February 2000

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

Genders Eligible for Study:

Both

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

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

T. +49 30 468 11800

More Information

Study ID Numbers:	303045
Study First Received:	September 13, 2005
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00185315
Health Authority:	France: Afssaps - French Health Products Safety Agency; Spain: Ministry of Health and Consumption; Portugal: National Pharmacy and Medicines Institute; POLAND: STÁTNÍ ÚSTAV PRO KONTROLU LÉČIV

Study placed in the following topic categories:

Iloprost
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Neoplasm Metastasis
Secondary pulmonary hypertension
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009