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TerminatedNCT00120380Updated Aug 21, 2012

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

A Phase 4 interventional study of Aerosolized iloprost and Placebo in Hypertension, sponsored by Hannover Medical School. Terminated at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-08-21.

Sponsored by Hannover Medical School · Phase 4, Interventional, and Treatment

Why this study was terminated
Futility analysis
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

Keywords

  • Idiopathic pulmonary arterial hypertension
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 40 is close to the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • other forms of pulmonary hypertension
  • severe comorbidities
  • cotreatment with sildenafil or investigational drugs
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Aerosolized Iloprost

    Drug: Aerosolized iloprost

  • Placebo comparator
    Bosentan monotherapy

    Drug: Placebo

Interventions

  • DrugAerosolized iloprost
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 6 minute walk test

07

Study locations

1 site
  • Hannover Medical School
    Hannover, 30625, Germany
08

References and documents

Publications

  • 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. PubMed 17012628 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00120380
Lead sponsor
Hannover Medical School
First posted
Jul 18, 2005
Start date
Sep 2004
Primary completion
May 2006
Completion
May 2006
Last update
Aug 21, 2012

Study contacts

Marius M Hoeper, MD
study chair · Hannover Medical School
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

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