Open-label Study With Bosentan in Interstitial Lung Disease (BUILD 2 OL)

This study has been completed.
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00319033
First received: April 26, 2006
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.


Condition Intervention Phase
Interstitial Lung Disease
Scleroderma
Drug: bosentan
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change from baseline to all assessed time points in 6-minute walk test distance.
  • Change from baseline to all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value).
  • Transition Dyspnea Index at all assessed time points.
  • Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 ≥ 4%), trough SpO2 and area under the curve during 6-minute walk test.

Secondary Outcome Measures:
  • Adverse events; serious adverse events.

Estimated Enrollment: 132
Study Start Date: July 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To have completed the 12-month treatment period of the AC-052-330/BUILD 2.
  • Women should not be pregnant
  • Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception
  • Signed informed consent prior to initiation of any study-mandated procedure

Exclusion Criteria:

  • Any major violation of the protocol AC-052-330.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319033

  Show 36 Study Locations
Sponsors and Collaborators
Actelion
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319033     History of Changes
Other Study ID Numbers: AC-052-332, BUILD 2 OL
Study First Received: April 26, 2006
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
interstitial lung disease
scleroderma
bosentan

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Lung Diseases
Lung Diseases, Interstitial
Connective Tissue Diseases
Skin Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014