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Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00060996
First Posted: May 20, 2003
Last Update Posted: March 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
May 19, 2003
May 20, 2003
March 7, 2013
February 2003
September 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00060996 on ClinicalTrials.gov Archive Site
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Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Continuous or Daily Administration of Remodulin® (Treprostinil Sodium) Injection in Patients With CLI With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Critical Limb Ischemia
  • Peripheral Vascular Disease
  • Foot Ulcers
  • Rest Leg Pain
Drug: Remodulin® (treprostinil sodium) Injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
September 2004
September 2004   (Final data collection date for primary outcome measure)
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00060996
REM 03:202
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United Therapeutics
United Therapeutics
Not Provided
Study Director: Michael Wade, PhD United Therapeutics
United Therapeutics
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP