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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01781052
First received: January 22, 2013
Last updated: April 22, 2014
Last verified: April 2014

January 22, 2013
April 22, 2014
September 2013
June 2015   (final data collection date for primary outcome measure)
Compliance of Ventavis use for each subject assessed by the mean daily number of inhalations and mean daily dose of Ventavis. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01781052 on ClinicalTrials.gov Archive Site
  • Compliance of Ventavis use for each subject assessed by the mean daily number of inhalations and mean daily dose of Ventavis [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Dyspnea Borg Category Ration 10 Scale values [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires) [ Time Frame: 6 and 12 months ] [ Designated as 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients aged ≥18 years and diagnosed with PAH (Pulmonary Arterial Hypertension), WHO/NYHA functional class III, Group I of the Dana point Pulmonary Hypertension Classification and newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I-Neb AAD device for the application.

Pulmonary Arterial Hypertension
Drug: 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.
Group 1
Intervention: Drug: Ventavis (Iloprost, BAYQ6256)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
November 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
France
 
NCT01781052
16133, VE1210FR, 2011/00416
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP