Safety Follow-up Study of Inhaled Iloprost in Patients Wi... | NCT00185315

Studies
Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension

NCT00185315

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 20, 2010Estimated

Enrollment

71Actual

Phase

Phase 3

Conditions

Hypertension, Pulmonary

Interventions

Ventavis (Iloprost, BAYQ6256)

Countries

Belgium
France
Italy
Netherlands
Poland
Portugal
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2000

Primary Completion Date

Not provided

Completion Date

Aug 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2010

Last Update Posted Date

Apr 20, 2010Estimated

Description Module

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.

Detailed Description

This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Ventavis (Iloprost, BAYQ6256)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ventavis (Iloprost, BAYQ6256)	Drug	Inhaled iloprost	Arm 1

Measure	Description	Time Frame
Adverse events		Throughout the whole study

Measure	Description	Time Frame
Tolerability of treatment		Over a minimum of 24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

71 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016285	Iloprost

Ancestor Terms

ID	Term
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Brussels		1070	Belgium

ID	Type	Description	Link
303045
Follow-up 90419-300180