check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

16777

ClinicalTrials.gov Identifier:

NCT01971450

EudraCT Number:

Not Available

EU CT Number:

Not Available
Non-interventional study on compliance of inhaled treatment with Ventavis in patient with pulmonary hypertension

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Male and female patients ≥ 18 years old
    - Diagnosis of PH
    - Planned or current treatment with Ventavis (not more than 6 month)
  • - Contraindications for the use of Ventavis in accordance with the local product information

Trial summary

Enrollment Goal
89
Trial Dates
November 2013 - April 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Russia

Primary Outcome

  • Number of days without any drug administration at all
    date_rangeTime Frame:
    Up to 12 months
  • Number of fully inhaled doses in relation to the total number of inhalations per day
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of missed doses per day as recommended
    date_rangeTime Frame:
    Up to 12 months
  • 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
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 6 minute walking distance test (MWDT) value
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Score on dyspnea Borg CR (category ratio) 10 scale
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Patients’ quality of life, assessed by validated questionnaire
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of the structural changes in the lungs using X-ray examination of the lungs
    date_rangeTime Frame:
    Up to 12 months
  • Assessment of the structural changes in the lungs using spirography
    date_rangeTime Frame:
    Up to 12 months
  • Assessment of lung haemodynamics using the data of echocardiography
    date_rangeTime Frame:
    Up to 12 months
  • Assessment of lung haemodynamics using the data of catheterization
    date_rangeTime Frame:
    Up to 12 months
  • Reason for omission of inhalation as assessed by the physician
    date_rangeTime Frame:
    Up to 12 months
  • Concomitant medication for other indications than pulmonary hypertension
    date_rangeTime Frame:
    Up to 12 months
  • Number of participants with adverse events (AEs)
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Severity of AEs
    date_rangeTime Frame:
    Up to 12 months
  • AE relation to treatment
    date_rangeTime Frame:
    Up to 12 months
  • AE treatment
    date_rangeTime Frame:
    Up to 12 months
  • AE outcomes
    date_rangeTime Frame:
    Up to 12 months

Trial design

Prospective multicentre non-interventional study on compliance of inhaled treatment with Ventavis in patient with pulmonary hypertension
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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