UT-15C SR in the Treatment of Critical Limb Ischemia
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|ClinicalTrials.gov Identifier: NCT00445159|
Recruitment Status : Unknown
Verified March 2007 by Southern Arizona Vascular Institute.
Recruitment status was: Recruiting
First Posted : March 8, 2007
Last Update Posted : March 8, 2007
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Drug: UT-15C SR (treprostinil diethanolamine) 1mg oral tablets||Phase 2|
This study is an eight week, two center, open-label study assessing the tolerability, safety, and efficacy of oral UT-15C sustained release tablets in subjects with CLI and ischemic lower limb rest pain, with or without an ischemic wound present. Conventional therapy should be continued without changes over the course of the study for all subjects.
Group 1: The first ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every seven days, depending on tolerability, to a maximum dose of 4mg/day .
Group 2: The last ten subjects to enroll in the study will be assigned to receive an initial dose of 1mg. The dose will be titrated upward every seven days, depending on tolerability to a maximum dose of 8 mg/day .
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||An Investigator Initiated Eight Week Two Center Open-Label Pilot Study of the Tolerability and Safety of Oral UT-15C (Treprostinil Diethanolamine)SR Tablets in Patients With Critical Limb Ischemia (CLI) and Ischemic Rest Pain|
|Study Start Date :||November 2006|
- To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain
- To assess the effect of UT-15C on the following disease symptoms associated with CLI:
- ž Ischemic rest pain
- ž Sleep interference
- ž Ambulatory status
- ž Ischemic wound healing (if applicable)
- To obtain peak and trough treprostinil plasma levels in CLI subjects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445159
|United States, Arizona|
|Southern Arizona Vascular Institute||Recruiting|
|Tucson, Arizona, United States, 85704|
|Contact: Sonia Voigt, RN 520-297-5846 email@example.com|
|Principal Investigator: Scott S Berman, MD|
|United States, Illinois|
|Southern Illinois University School of Medicine||Recruiting|
|Springfield, Illinois, United States, 62794-9638|
|Contact: Carol Buettner 217-545-2320 firstname.lastname@example.org|
|Principal Investigator: Colleen Johnson, MD|
|Principal Investigator:||Colleen Johnson, MD||Southern Illinois University|
|Principal Investigator:||Scott S Berman, MD||Southern Arizona Vascular Institute|