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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00067041
Other study ID # REM03:203
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received August 8, 2003
Last updated March 5, 2013
Start date March 2003
Est. completion date December 2003

Study information

Verified date March 2013
Source United Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date December 2003
Est. primary completion date December 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility - Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Remodulin (treprostinil sodium) Injection


Locations

Country Name City State
United States Vascular Institute Albany Medical College Albany New York
United States Oregon Health Sciences University Portland Oregon
United States Southern Illinois University School of Medicine Springfield Illinois
United States University of Massachusetts Memorial Health Center Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

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