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 September 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01971450
First received: September 20, 2013
Last updated: September 5, 2014
Last verified: September 2014
  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 ] [ Designated as safety issue: No ]
  • Number of fully inhaled doses in total versus the recommended number as a measure of compliance [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 minute walking distance test (MWDT) value [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Score on dyspnea Borg CR (category ratio) 10 scale [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Patients' quality of life, assessed by validated questionnaire [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01971450

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01971450     History of Changes
Other Study ID Numbers: 16777, VE1311RU
Study First Received: September 20, 2013
Last Updated: September 5, 2014
Health Authority: Russia: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 16, 2014