Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension (IVENT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01971450
First received: September 20, 2013
Last updated: October 2, 2014
Last verified: October 2014

September 20, 2013
October 2, 2014
December 2013
April 2016   (final data collection date for primary outcome measure)
  • Number of fully inhaled doses per day versus the recommended number as a measure of compliance [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Number of fully inhaled doses in total versus the recommended number as a measure of compliance [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01971450 on ClinicalTrials.gov Archive Site
  • 6 minute walking distance test (MWDT) value [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Score on dyspnea Borg CR (category ratio) 10 scale [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Patients' quality of life, assessed by validated questionnaire [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.

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

Male and female patients ≥ 18 years old with PH, treated with Ventavis and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.

Hypertension, Pulmonary
Drug: Iloprost (Ventavis, BAYQ6256)
Iloprost
The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.
Intervention: Drug: Iloprost (Ventavis, BAYQ6256)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients ≥ 18 years old
  • Diagnosis of PH
  • Planned or current treatment with Ventavis (not more than 6 month)

Exclusion Criteria:

  • Contraindications for the use of Ventavis in accordance with the local product information
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Russian Federation
 
NCT01971450
16777, VE1311RU
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2014

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