Efficacy of Ventavis Used in Real-life Setting. | NCT01355380

Studies
Efficacy of Ventavis Used in Real-life Setting.

NCT01355380

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 17, 2017Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Pulmonary Arterial Hypertension

Interventions

Inhaled iloprost (Ventavis, BAYQ6256)

Countries

Poland

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

ID	Type	Description	Link
VE1010PL	Other Identifier	Company internal

Status Module

Record Verification Date

Oct 2017

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

Aug 5, 2010Actual

Primary Completion Date

Apr 28, 2016Actual

Completion Date

Sep 22, 2016Actual

First Submitted Date

May 17, 2011

First Submission Date that Met QC Criteria

May 17, 2011

First Posted Date

May 18, 2011Estimated

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

Oct 16, 2017

Last Update Posted Date

Oct 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.

Typical clinical measures and quality of life will be prospectively followed in 12 months period.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Drug (incl. Placebo)	Drug: Inhaled iloprost (Ventavis, BAYQ6256)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inhaled iloprost (Ventavis, BAYQ6256)	Drug	Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of the exercise capacity as measured by 6-minutes walking distance		3, 6, 9 and 12 months vs. baseline

Secondary Outcomes

Measure	Description	Time Frame
Changes of depression score over time		3, 6, 9 and 12 months vs. baseline
Changes of functional capacity as measured by WHO classification system		3, 6, 9 and 12 months vs. baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pulmonary arterial hypertension in WHO functional class III or IV
Age 18+
Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria:

Retrospective documentation is not allowed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.

Sampling Method

Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract 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