Trial Condition(s):
Hypertension, Pulmonary
Non-interventional study on compliance of inhaled treatment with Ventavis in patient with pulmonary hypertension (IVENT)
Bayer Identifier:
16777
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
1
Primary Outcome
- Number of days without any drug administration at allTimeframe: Up to 12 months
- Number of fully inhaled doses in relation to the total number of inhalations per dayTimeframe: Up to 12 months
- Number of missed doses per day as recommendedTimeframe: 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 labelTimeframe: Up to 12 months
Secondary Outcome
- 6 minute walking distance test (MWDT) valueTimeframe: Up to 12 months
- Score on dyspnea Borg CR (category ratio) 10 scaleTimeframe: Up to 12 months
- Patients’ quality of life, assessed by validated questionnaireTimeframe: Up to 12 months
- Assessment of the structural changes in the lungs using X-ray examination of the lungsTimeframe: Up to 12 months
- Assessment of the structural changes in the lungs using spirographyTimeframe: Up to 12 months
- Assessment of lung haemodynamics using the data of echocardiographyTimeframe: Up to 12 months
- Assessment of lung haemodynamics using the data of catheterizationTimeframe: Up to 12 months
- Reason for omission of inhalation as assessed by the physicianTimeframe: Up to 12 months
- Concomitant medication for other indications than pulmonary hypertensionTimeframe: Up to 12 months
- Number of participants with adverse events (AEs)Timeframe: Up to 12 months
- Severity of AEsTimeframe: Up to 12 months
- AE relation to treatmentTimeframe: Up to 12 months
- AE treatmentTimeframe: Up to 12 months
- AE outcomesTimeframe: Up to 12 months
Additional Information
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