Study Completed

Pulmonary Arterial Hypertension

Bayer Identifier:

16133

ClinicalTrials.gov Identifier:

NCT01781052

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

Trial Dates

September 2013 - January 2017

Phase

Phase 4

Could I Receive a placebo

Products

Ventavis (Iloprost, BAYQ6256)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, France

Primary Outcome

Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
Time Frame:
Up to 12 months
Safety Issue:
No

Secondary Outcome

Compliance for each subject assessed by the mean daily number of inhalations of Ventavis
Time Frame:
Up to 6 months
Safety Issue:
No
Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test
Time Frame:
6 and 12 months
Safety Issue:
No
Dyspnea Borg Category Ration 10 Scale values
Time Frame:
6 and 12 months
Safety Issue:
No
Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)
Time Frame:
6 and 12 months
Safety Issue:
No
Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale
Time Frame:
Up to 12 months
Safety Issue:
No
Population characteristics
sociodemography, clinical aspects, risk factors
Time Frame:
At baseline

Trial design

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

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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