check_circleStudy Completed

Primary Hypertension

Bayer Identifier:

14183

ClinicalTrials.gov Identifier:

NCT00882947

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

Both

Age

18 - 65 Years
  • - 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.
  • - Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.

Trial summary

Enrollment Goal
38
Trial Dates
February 2006 - September 2008
Phase
N/A
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, China

Primary Outcome

  • Frequency of Adverse Events
    date_rangeTime Frame:
    At week 4,12 and 24
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • 6 minute walking test (6-MWT)
    date_rangeTime Frame:
    At week 4,12 and 24
    enhanced_encryption
    Safety Issue:
    no
  • NYHA functional class
    date_rangeTime Frame:
    At week 4,12 and 24
    enhanced_encryption
    Safety Issue:
    no

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
N/A

Additional Information

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