NCT00185315

Brief Summary

The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_3

Geographic Reach
7 countries

16 active sites

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, 2000

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

April 20, 2010

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

April 19, 2010

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Throughout the whole study

Secondary Outcomes (1)

  • Tolerability of treatment

    Over a minimum of 24 months

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Ventavis (Iloprost, BAYQ6256)

Interventions

Ventavis (Iloprost, BAYQ6256)DRUG

Inhaled iloprost

Arm 1

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of the 12-week treatment period of the predecessor Schering study 97218/300180
  • Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient
  • Negative pregnancy test for females

You may not qualify if:

  • Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Brussels, 1070, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Clamart, 92141, France

Location

Unknown Facility

Grenoble, 38043, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Reims, 51092, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Bologna, BO, 40138, Italy

Location

Unknown Facility

Montescano, Pavia, 27040, Italy

Location

Unknown Facility

Pisa, PI, 56100, Italy

Location

Unknown Facility

Amsterdam, 1081 HV, Netherlands

Location

Unknown Facility

Warsaw, 01138, Poland

Location

Unknown Facility

Coimbra, 3000-076, Portugal

Location

Unknown Facility

Vila Nova de Gaia, 4434-506, Portugal

Location

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Madrid, Madrid, 28041, Spain

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
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

February 1, 2000

Study Completion

August 1, 2005

Last Updated

April 20, 2010

Record last verified: 2010-04

Locations

PL(1)PT(2)BE(2)FR(5)IT(3)ES(2)NL(1)