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

NCT ID: NCT00882947

Last Updated: 2009-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Ventavis (Iloprost, BAYQ6256)

Intervention Type DRUG

Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

Interventions

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Ventavis (Iloprost, BAYQ6256)

Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Schering Pharma AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , China

Site Status

Countries

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China

Other Identifiers

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VE0611CN

Identifier Type: -

Identifier Source: secondary_id

14183

Identifier Type: -

Identifier Source: org_study_id

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