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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01971450
First Posted: October 29, 2013
Last Update Posted: September 25, 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
September 20, 2013
October 29, 2013
September 25, 2017
December 15, 2013
June 28, 2017   (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 ]
  • Number of fully inhaled doses in total versus the recommended number as a measure of compliance [ Time Frame: Up to 12 months ]
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 ]
  • Score on dyspnea Borg CR (category ratio) 10 scale [ Time Frame: Up to 12 months ]
  • Patients' quality of life, assessed by validated questionnaire [ Time Frame: Up to 12 months ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 months ]
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.
 
Active, not recruiting
59
November 30, 2017
June 28, 2017   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT01971450
16777
VE1311RU ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2017