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Trial record 1 of 1 for:    NCT01971450
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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 : Completed
First Posted : October 29, 2013
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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
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Study Type : Observational
Actual Enrollment : 89 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 : November 21, 2013
Actual Primary Completion Date : June 28, 2017
Actual Study Completion Date : April 18, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost

Groups and Cohorts
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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
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Primary Outcome Measures :
  1. Number of days without any drug administration at all [ Time Frame: Up to 12 months ]
  2. Number of fully inhaled doses in relation to the total number of inhalations per day [ Time Frame: Up to 12 months ]
  3. Number of missed doses per day as recommended [ Time Frame: Up to 12 months ]
  4. Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label [ 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. Assessment of the structural changes in the lungs using X-ray examination of the lungs [ Time Frame: Up to 12 months ]
  5. Assessment of the structural changes in the lungs using spirography [ Time Frame: Up to 12 months ]
  6. Assessment of lung haemodynamics using the data of echocardiography [ Time Frame: Up to 12 months ]
  7. Assessment of lung haemodynamics using the data of catheterization [ Time Frame: Up to 12 months ]
  8. Reason for omission of inhalation as assessed by the physician [ Time Frame: Up to 12 months ]
  9. Concomitant medication for other indications than pulmonary hypertension [ Time Frame: Up to 12 months ]
  10. Number of participants with adverse events (AEs) [ Time Frame: Up to 12 months ]
  11. Severity of AEs [ Time Frame: Up to 12 months ]
  12. AE relation to treatment [ Time Frame: Up to 12 months ]
  13. AE treatment [ Time Frame: Up to 12 months ]
  14. AE outcomes [ Time Frame: Up to 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Russian Federation
Multiple Locations, Russian Federation
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01971450    
Other Study ID Numbers: 16777
VE1311RU ( Other Identifier: Company internal )
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Non-interventional
Ventavis
Iloprost
 Pulmonary hypertension
Compliance
Russian Federation
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents