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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-11

Study Completion Date

2017-01-16

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Keywords

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Iloprost Compliance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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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

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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

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , France

Site Status

Countries

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France

Other Identifiers

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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