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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00882947
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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.


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:

Drug Information available for: Iloprost
U.S. FDA Resources

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

n.a.


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

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00882947

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

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov 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
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013