Trial Condition(s):
Primary Hypertension
Post-Marketing Surveillance of Ventavis® in Chinese Patients with Primary Pulmonary Hypertension (PPH)
Bayer Identifier:
14183
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
- Both male and female age 18-65 years old - The treating physician has chosen Ventavis as a suitable long-term treatment for the patient - Patient with Primary Pulmonary Hypertension (i.e. IPAH or FPAH) and classified as NYHA functional class III - Written informed/data protection consent - No prior treatment with Ventavis or other active treatments for PPH within 6 weeks of date of study.
Exclusion Criteria
- Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.
Trial Summary
Enrollment Goal
38
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
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Post-Marketing Surveillance of Ventavis® in Chinese Patients with Primary Pulmonary Hypertension (PPH)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Frequency of Adverse EventsTimeframe: At week 4,12 and 24
Secondary Outcome
- 6 minute walking test (6-MWT)Timeframe: At week 4,12 and 24
- NYHA functional classTimeframe: At week 4,12 and 24
Additional Information
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