NCT01062282

Brief Summary

The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 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

July 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
Last Updated

April 4, 2011

Status Verified

April 1, 2011

Enrollment Period

2.9 years

First QC Date

August 20, 2009

Last Update Submit

April 1, 2011

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable is 6-minute walking distance

    At baseline and month 1,3,6 for an observational period of 6 months

Secondary Outcomes (4)

  • New York Heart Association functional class

    Baseline, month 1,3,6

  • PH-related symptoms and change of concomitant medication

    Baseline, month 1,3,6

  • Hemodynamic parameters

    If applicable ( at any time during Ventavis treatment)

  • Adverse Event collection

    If applicable (during the study period)

Study Arms (1)

Group 1

Drug: Iloprost (Ventavis BAYQ6256)

Interventions

Iloprost (Ventavis BAYQ6256)DRUG

Patients with pulmonary arterial hypertension, classified as New York Heart Association functional class III or IV where the treating physician has chosen Ventavis as a suitable treatment prior to inclusion into this non-interventional study. Patients should not have received prior treatment with Ventavis

Group 1

Eligibility Criteria

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

Patients with pulmonary hypertension in Korea

You may qualify if:

  • The treating physician has chosen Ventavis as a suitable treatment for the patient
  • Patient with PH and classified as NYHA functional class III or IV and WHO group 1

You may not qualify if:

  • Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient package insert).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 20, 2009

First Posted

February 4, 2010

Study Start

July 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 4, 2011

Record last verified: 2011-04

Locations

KR(1)