We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781052
First Posted: January 31, 2013
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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.

Condition Intervention
Pulmonary Arterial Hypertension Drug: Ventavis (Iloprost, BAYQ6256)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires) [ 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 ]

Enrollment: 17
Study Start Date: September 2013
Study Completion Date: January 2017
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781052


Locations
France
Many Locations, France
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01781052     History of Changes
Other Study ID Numbers: 16133
VE1210FR ( Other Identifier: Company internal )
2011/00416 ( Other Identifier: Company internal )
First Submitted: January 22, 2013
First Posted: January 31, 2013
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Bayer:
Iloprost Compliance

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents


To Top