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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 ]

Secondary Outcome Measures:
  • 6 minute walking test (6-MWT) [ Time Frame: At week 4,12 and 24 ]
  • NYHA functional class [ Time Frame: At week 4,12 and 24 ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Bayer:
Primary Pulmonary Hypertension (PPH)

Additional relevant MeSH terms:
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents processed this record on April 27, 2017