Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)

This study has been completed.
Information provided by:
Bayer Identifier:
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

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.

Condition Intervention Phase
Primary Hypertension
Drug: Ventavis (Iloprost, BAYQ6256)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Frequency of Adverse Events [ Time Frame: At week 4,12 and 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 6 minute walking test (6-MWT) [ Time Frame: At week 4,12 and 24 ] [ Designated as safety issue: No ]
  • NYHA functional class [ Time Frame: At week 4,12 and 24 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained


Enrollment: 38
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Ventavis (Iloprost, BAYQ6256)
Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult Chinese patients (age 18-65 male and female) with Primary Pulmonary Hypertension


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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00882947

Many Locations, China
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG Identifier: NCT00882947     History of Changes
Other Study ID Numbers: 14183, VE0611CN
Study First Received: April 16, 2009
Last Updated: April 16, 2009
Health Authority: China: Ethics Committee

Keywords provided by Bayer:
Primary Pulmonary Hypertension (PPH)

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents processed this record on April 17, 2014