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Circulase in Critical Leg Ischemia
NCT00059644Phase 3
Key facts
- Status
- Terminated
- Start
- Jul 2001
- Countries
- 2
- Modality
- Small Molecules
- Drugs
- ecraprost
- Conditions
- critical limb ischemia (CLI)
01
Overview
Phase 3, randomised, double-blind trial in critical limb ischemia (CLI) comparing Circulase with Placebo (2 arms). Primary endpoint: Composite of Major Amputation or Death at 6 months. Started Jul 2001; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Circulase
Circulase (ecraprost) 60 mcg IV
Placebo
Placebo IV
03
Who it enrols
Patients with critical leg ischemia who have exhausted all standard revascularization treatment options, excluding those with prior major amputation or end-stage renal disease.
04
Endpoints
Primary
Composite of Major Amputation or Death
Secondary
Major Amputation Rate
Critical Cardiovascular Events
Complete Ulcer Healing
Pain at Rest
Quality of Life
Hemodynamic Measurements
Neuropathy Improvement
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