Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

NCT ID: NCT01781052

Last Updated: 2017-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-11
• Study Completion Date: 2017-01-16

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Ventavis (Iloprost, BAYQ6256)

Intervention Type: DRUG

Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session.

Interventions

Ventavis (Iloprost, BAYQ6256)

Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Multiple Locations, , France

Countries

France

Other Identifiers

VE1210FR

Identifier Type: OTHER

Identifier Source: secondary_id

2011/00416

Identifier Type: OTHER

Identifier Source: secondary_id

16133

Identifier Type: -

Identifier Source: org_study_id