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Trial record 7 of 914 for:    "Hypertension, Pulmonary"

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
  Purpose
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 ]

Enrollment: 59
Actual Study Start Date: December 15, 2013
Estimated Study Completion Date: November 30, 2017
Primary Completion Date: June 28, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Iloprost
The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.
Drug: Iloprost (Ventavis, BAYQ6256)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Many 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 Submitted: September 20, 2013
First Posted: October 29, 2013
Last Update Posted: September 25, 2017
Last Verified: September 2017

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