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

Bayer38 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Primary Hypertension

Interventions

Ventavis (Iloprost, BAYQ6256)DRUG

Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Many Locations, China

Outcomes

Primary Outcomes

Frequency of Adverse Events

Time frame: At week 4,12 and 24

Secondary Outcomes

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

Data from ClinicalTrials.gov

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