IRB Number:

1036-03

Trial Status:

Inactive

Phase: II

Why is this study being done?

The purpose of the research study is:

• to evaluate the effectiveness, safety and tolerability of a drug called bosenatan compared to a placebo (an inactive substance) in Idiopathic Pulmonary Fibrosis (IPF).


• to demonstrate that bosentan improves 6-minute walk distance in Idiopathic Pulmonary Fibrosis (IPF) patients.

Who is Eligible to Participate in the Study?

Men or women over the age of 18 diagnosed with Idiopathic Pulmonary Fibrosis (IPF) may be eligible to participate in this research study.

Minimum Age:

18

Maximum Age:

100

What is Involved With this Study?

This research study will require 12 visits over approximately 2 years.

The tests performed during the study will include:

• Physical examination, medical history, and vital signs


• Lung function and arterial blood gases


• HRCT


• ECG


• Routine laboratory tests


• Patient questionnaires

How long will the Study run?

Participants will be enrolled in this study for approximately two years.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact Boleyn Hammel at (507) 284-4619 or 1-800-753-1606.

The principal investigator for this research study is Sanjay Kalra, M.D.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 10/27/2005