check_circleStudy Completed
Pulmonary Hypertension
Bayer Identifier:
14184
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
41Trial Dates
July 2006 - June 2009Phase
N/ACould I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Korea, Republic Of |
Primary Outcome
- The primary efficacy variable is 6-minute walking distancedate_rangeTime Frame:At baseline and month 1,3,6 for an observational period of 6 monthsenhanced_encryptionyesSafety Issue:
Secondary Outcome
- New York Heart Association functional classdate_rangeTime Frame:Baseline, month 1,3,6enhanced_encryptionnoSafety Issue:
- PH-related symptoms and change of concomitant medicationdate_rangeTime Frame:Baseline, month 1,3,6enhanced_encryptionnoSafety Issue:
- Hemodynamic parametersdate_rangeTime Frame:If applicable ( at any time during Ventavis treatment)enhanced_encryptionNoSafety Issue:
- Adverse Event collectiondate_rangeTime Frame:If applicable (during the study period)enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A