NCT00882947

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

2.6 years

First QC Date

April 16, 2009

Last Update Submit

April 16, 2009

Conditions

Primary Hypertension

Keywords

Primary Pulmonary Hypertension (PPH)

Outcome Measures

Primary Outcomes (1)

  • Frequency of Adverse Events

    At week 4,12 and 24

Secondary Outcomes (2)

  • 6 minute walking test (6-MWT)

    At week 4,12 and 24

  • NYHA functional class

    At week 4,12 and 24

Study Arms (1)

Group 1

Drug: Ventavis (Iloprost, BAYQ6256)

Interventions

Ventavis (Iloprost, BAYQ6256)DRUG

Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog

Group 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Chinese patients (age 18-65 male and female) with Primary Pulmonary Hypertension

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, China

Location

MeSH Terms

Conditions

Essential HypertensionFamilial Primary Pulmonary Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesHypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

February 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

CN(1)