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

Primary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882947
• Other study ID #: 14183
• Secondary ID: VE0611CN
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2009
• Last updated: April 16, 2009
• Start date: February 2006
• Est. completion date: September 2008

Study information

• Verified date: April 2009
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Primary Hypertension

Intervention

Drug:
• Ventavis (Iloprost, BAYQ6256)
Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events		At week 4,12 and 24	Yes
Secondary	6 minute walking test (6-MWT)		At week 4,12 and 24	No
Secondary	NYHA functional class		At week 4,12 and 24	No

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