Trial Condition(s):
Pulmonary hypertension
Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)
Bayer Identifier:
14184
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.
Inclusion Criteria
- The treating physician has chosen Ventavis as a suitable treatment for the patient - Patient with PH and classified as NYHA functional class III or IV and WHO group 1
Exclusion Criteria
- Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient package insert).
Trial Summary
Enrollment Goal
41
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
VENIS - Prospective observational study of Ventavis® inhalation therapy in the treatment of patients with pulmonary arterial 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
- The primary efficacy variable is 6-minute walking distanceTimeframe: At baseline and month 1,3,6 for an observational period of 6 months
Secondary Outcome
- New York Heart Association functional classTimeframe: Baseline, month 1,3,6
- PH-related symptoms and change of concomitant medicationTimeframe: Baseline, month 1,3,6
- Hemodynamic parametersTimeframe: If applicable ( at any time during Ventavis treatment)
- Adverse Event collectionTimeframe: If applicable (during the study period)
Additional Information
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