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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01781052
• Date of registration: 22/01/2013
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients DAILY
• Scientific title: DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
• Date of first enrolment: September 11, 2013
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01781052
• Study type: Observational
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Ventavis (Iloprost, BAYQ6256)

Primary Outcome(s)

Compliance for each subject assessed by the mean daily number of inhalations of Ventavis. [Time Frame: Up to 12 months]

Secondary Outcome(s)

Compliance for each subject assessed by the mean daily number of inhalations of Ventavis [Time Frame: Up to 6 months]

Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires) [Time Frame: 6 and 12 months]

Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test [Time Frame: 6 and 12 months]

Dyspnea Borg Category Ration 10 Scale values [Time Frame: 6 and 12 months]

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]

Population characteristics [Time Frame: At baseline]

Secondary ID(s)

16133

VE1210FR

2011/00416

Source(s) of Monetary Support

Please refer to primary and secondary sponsors