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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 May 2017 by Bayer
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 20, 2013
Last updated: May 2, 2017
Last verified: May 2017
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Actual Study Start Date: December 15, 2013
Estimated Study Completion Date: August 31, 2017
Estimated Primary Completion Date: May 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.
Drug: Iloprost (Ventavis, BAYQ6256)


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
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01971450

Contact: Bayer Clinical Trials Contact

Russian Federation
Many locations, Russian Federation
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01971450     History of Changes
Other Study ID Numbers: 16777
VE1311RU ( Other Identifier: Company internal )
Study First Received: September 20, 2013
Last Updated: May 2, 2017

Keywords provided by Bayer:
Pulmonary hypertension
Russian Federation

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents processed this record on May 23, 2017