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

Hypertension, Pulmonary Clinical Trial

— IVENT  

Official title:

Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971450
• Other study ID #: 16777
• Secondary ID: VE1311RU
• Status: Completed
• Start date: November 21, 2013
• Est. completion date: April 18, 2018

Study information

• Verified date: March 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 18, 2018
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Iloprost (Ventavis, BAYQ6256)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days without any drug administration at all		Up to 12 months
Primary	Number of fully inhaled doses in relation to the total number of inhalations per day		Up to 12 months
Primary	Number of missed doses per day as recommended		Up to 12 months
Primary	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		Up to 12 months
Secondary	6 minute walking distance test (MWDT) value		Up to 12 months
Secondary	Score on dyspnea Borg CR (category ratio) 10 scale		Up to 12 months
Secondary	Patients' quality of life, assessed by validated questionnaire		Up to 12 months
Secondary	Assessment of the structural changes in the lungs using X-ray examination of the lungs		Up to 12 months
Secondary	Assessment of the structural changes in the lungs using spirography		Up to 12 months
Secondary	Assessment of lung haemodynamics using the data of echocardiography		Up to 12 months
Secondary	Assessment of lung haemodynamics using the data of catheterization		Up to 12 months
Secondary	Reason for omission of inhalation as assessed by the physician		Up to 12 months
Secondary	Concomitant medication for other indications than pulmonary hypertension		Up to 12 months
Secondary	Number of participants with adverse events (AEs)		Up to 12 months
Secondary	Severity of AEs		Up to 12 months
Secondary	AE relation to treatment		Up to 12 months
Secondary	AE treatment		Up to 12 months
Secondary	AE outcomes		Up to 12 months

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