NCT00120380

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

August 21, 2012

Status Verified

January 1, 2006

Enrollment Period

1.7 years

First QC Date

July 11, 2005

Last Update Submit

August 20, 2012

Conditions

Hypertension

Keywords

Idiopathic pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk test

Study Arms (2)

Aerosolized Iloprost

ACTIVE COMPARATOR
Drug: Aerosolized iloprost

Bosentan monotherapy

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Aerosolized iloprostDRUG
Aerosolized Iloprost
PlaceboDRUG
Bosentan monotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17012628RESULT

MeSH Terms

Conditions

HypertensionFamilial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marius M Hoeper, MD

    Hannover Medical School

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2005

First Posted

July 18, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

August 21, 2012

Record last verified: 2006-01

Locations

DE(1)