Combination Therapy of Bosentan and Aerosolized Iloprost... | NCT00120380

Studies
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)

NCT00120380

Sponsor

Hannover Medical School

Status

Terminated

Last Update Posted

Aug 21, 2012Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Aerosolized iloprost
Placebo

Countries

Germany

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

Jan 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Futility analysis

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Jul 11, 2005

First Submission Date that Met QC Criteria

Jul 15, 2005

First Posted Date

Jul 18, 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

Aug 20, 2012

Last Update Posted Date

Aug 21, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to test whether the addition of inhaled iloprost is safe and effective in patients with idiopathic pulmonary arterial hypertension who are already being treated with the endothelin receptor antagonist bosentan.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aerosolized Iloprost	Active Comparator		Drug: Aerosolized iloprost
Bosentan monotherapy	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerosolized iloprost	Drug		Aerosolized Iloprost
Placebo

Measure	Description	Time Frame
6 minute walk test

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IPAH
> 3 months treatment with bosentan
6 minute walk distance 150 - 425 m

Exclusion Criteria:

other forms of pulmonary hypertension
severe comorbidities
cotreatment with sildenafil or investigational drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marius M Hoeper, MD	Hannover Medical School	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School		Hanover		30625	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17012628	Result	Hoeper MM, Leuchte H, Halank M, Wilkens H, Meyer FJ, Seyfarth HJ, Wensel R, Ripken F, Bremer H, Kluge S, Hoeffken G, Behr J. Combining inhaled iloprost with bosentan in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2006 Oct;28(4):691-4. doi: 10.1183/09031936.06.00057906.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006976	Hypertension, Pulmonary
D008171	Lung Diseases

ID	Term
D006973	Hypertension
D065627	Familial Primary Pulmonary Hypertension