check_circleStudy 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
  • - 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

  • 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
September 2013 - January 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France

Primary Outcome

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

Secondary Outcome

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