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

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ClinicalTrials.gov Identifier: NCT01971450
Recruitment Status : Active, not recruiting
First Posted : October 29, 2013
Last Update Posted : January 15, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Hypertension, Pulmonary Drug: Iloprost (Ventavis, BAYQ6256)

Study Design

Study Type : Observational
Actual Enrollment : 59 participants
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
Actual Study Start Date : December 15, 2013
Primary Completion Date : June 28, 2017
Estimated Study Completion Date : February 7, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Iloprost
The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.
Drug: Iloprost (Ventavis, BAYQ6256)


Outcome Measures

Primary Outcome Measures :
  1. Number of fully inhaled doses per day versus the recommended number as a measure of compliance [ Time Frame: Up to 12 months ]
  2. 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 :
  1. 6 minute walking distance test (MWDT) value [ Time Frame: Up to 12 months ]
  2. Score on dyspnea Borg CR (category ratio) 10 scale [ Time Frame: Up to 12 months ]
  3. Patients' quality of life, assessed by validated questionnaire [ Time Frame: Up to 12 months ]
  4. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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.
Criteria

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

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): NCT01971450


Locations
Russian Federation
Multiple Locations, Russian Federation
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01971450     History of Changes
Other Study ID Numbers: 16777
VE1311RU ( Other Identifier: Company internal )
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018

Keywords provided by Bayer:
Non-interventional
Ventavis
Iloprost
Pulmonary hypertension
Compliance
Russian Federation

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