Trial Condition(s):

Pulmonary arterial hypertension

Observational description of Compliance for the daily Ventavis use via the Insight program in class III Pulmonary Arterial Hypertension patients (DAILY)

Bayer Identifier:

16133

ClinicalTrials.gov Identifier:

NCT01781052

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.

Inclusion Criteria
-  Male or female subjects aged ≥18 years
 -  Newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I Neb AAD device for the application, as described in the SmPC (Summary of Product Characteristics), complemented by the Insight
 -  With Pulmonary Arterial Hypertension, Group I of the Dana point Pulmonary Hypertension Classification.
 -  WHO (World Health Organization) /NYHA (New York Heart Association) Functional class III
 -  Able and willing to give written informed consent for participation in the study
Exclusion Criteria
Key contra indications:
 -  Hypersensitivity to the active substance or to any of the excipients. 
 -  Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage). 
 -  Severe coronary heart disease or unstable angina; 
 -  Myocardial infarction within the last six months; 
 -  Decompensated cardiac failure if not under close medical supervision; 
 -  Severe arrhythmias; 
 -  Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months. 
 -  Pulmonary hypertension due to venous occlusive disease. 
 -  Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension

Trial Summary

Enrollment Goal
17
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, France

Status
Completed
 

Trial Design