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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00060996
First received: May 19, 2003
Last updated: March 5, 2013
Last verified: March 2013

May 19, 2003
March 5, 2013
February 2003
September 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Critical Limb Ischemia
  • Peripheral Vascular Disease
  • Foot Ulcers
  • Rest Leg Pain
Drug: Remodulin® (treprostinil sodium) Injection
Not Provided
Not Provided

*   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

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00060996
REM 03:202
Not Provided
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