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CompletedNCT00882947Updated Apr 17, 2009

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

An observational study in Primary Hypertension, sponsored by Bayer. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-04-17.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
38
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Hypertension

Keywords

  • Primary Pulmonary Hypertension (PPH)
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 38 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
38 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Ventavis (Iloprost, BAYQ6256)

Interventions

  • DrugVentavis (Iloprost, BAYQ6256)

    Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

06

What researchers measure

Primary outcomes

  1. Frequency of Adverse Events

    Time frame: At week 4,12 and 24

Secondary outcomes

  1. 6 minute walking test (6-MWT)

    Time frame: At week 4,12 and 24

  2. NYHA functional class

    Time frame: At week 4,12 and 24

07

Study locations

1 site
  • Many Locations, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00882947
Lead sponsor
Bayer
First posted
Apr 17, 2009
Start date
Feb 2006
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Apr 17, 2009

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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