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| Descriptive Information Fields | |||||
| Brief Title † | Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures | ||||
| Official Title † | 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Critical Limb Ischemia Peripheral Vascular Disease Foot Ulcers Rest Leg Pain |
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| Intervention † | Drug: Remodulin® (treprostinil sodium) Injection | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 30 | ||||
| Start Date † | February 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures |
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00060996 | ||||
| Organization ID | REM 03:202 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | United Therapeutics | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | United Therapeutics | ||||
| Verification Date | October 2004 | ||||
| First Received Date † | May 19, 2003 | ||||
| Last Updated Date | June 23, 2005 | ||||