Overview

This trial has been completed.

Condition pulmonary arterial hypertension
Treatment inhaled iloprost (ventavis, bayq6256)
Phase phase 4
Sponsor Bayer
Start date August 2010
End date April 2016
Trial size 52 participants
Trial identifier NCT01355380, 15308, VE1010PL

Summary

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.

Typical clinical measures and quality of life will be prospectively followed in 12 months period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Drug (incl. Placebo)
inhaled iloprost (ventavis, bayq6256)
Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily

Primary Outcomes

Measure
Changes of the exercise capacity as measured by 6-minutes walking distance
time frame: 3, 6, 9 and 12 months vs. baseline

Secondary Outcomes

Measure
Changes of depression score over time
time frame: 3, 6, 9 and 12 months vs. baseline
Changes of functional capacity as measured by WHO classification system
time frame: 3, 6, 9 and 12 months vs. baseline
Changes of pulmonary haemodynamics
time frame: 3, 6, 9 and 12 months vs. baseline
Changes of serum level of natriuretic peptide B
time frame: 3, 6, 9 and 12 months vs. baseline
Changes of Quality of Life score
time frame: 3, 6, 9 and 12 months vs. baseline

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Pulmonary arterial hypertension - Age 18+ - Patients newly treated with Ventavis or switched from sildenafil Exclusion Criteria: - Retrospective documentation is not allowed

Additional Information

Official title The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.