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OpenTrials
Completed

NCT Number: NCT00185315

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

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

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventavis (Iloprost, BAYQ6256)

Drug

Inhaled iloprost

Primary outcomes

  1. Adverse events

    Time frame: Throughout the whole study

Secondary outcomes

  1. Tolerability of treatment

    Time frame: Over a minimum of 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2000
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Apr 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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