check_circleStudy Completed
Primary Hypertension
Bayer Identifier:
14183
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Post-Marketing Surveillance of Ventavis® in Chinese Patients with Primary Pulmonary Hypertension (PPH)
Trial purpose
The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
38Trial Dates
February 2006 - September 2008Phase
N/ACould I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, China |
Primary Outcome
- Frequency of Adverse Eventsdate_rangeTime Frame:At week 4,12 and 24enhanced_encryptionyesSafety Issue:
Secondary Outcome
- 6 minute walking test (6-MWT)date_rangeTime Frame:At week 4,12 and 24enhanced_encryptionnoSafety Issue:
- NYHA functional classdate_rangeTime Frame:At week 4,12 and 24enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A