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

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.
 
ClinicalTrials.gov Identifier: NCT00060996
Recruitment Status : Terminated
First Posted : May 20, 2003
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Tracking Information
First Submitted Date  ICMJE May 19, 2003
First Posted Date  ICMJE May 20, 2003
Last Update Posted Date March 7, 2013
Study Start Date  ICMJE February 2003
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00060996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Limb Ischemia
  • Peripheral Vascular Disease
  • Foot Ulcers
  • Rest Leg Pain
Intervention  ICMJE Drug: Remodulin® (treprostinil sodium) Injection
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00060996
Other Study ID Numbers  ICMJE REM 03:202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party United Therapeutics
Study Sponsor  ICMJE United Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Wade, PhD United Therapeutics
PRS Account United Therapeutics
Verification Date March 2013

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