Study 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

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

Trial Dates

February 2006 - September 2008

Phase

N/A

Could I Receive a placebo

Products

Ventavis (Iloprost, BAYQ6256)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, China

Primary Outcome

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

Secondary Outcome

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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.