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Ruboxistaurin for vascular and neural function in T2DM
NCT00482976Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2003
- Countries
- 1
- Sponsor
- Chromaderm
- Modality
- Small Molecules
- Drugs
- ruboxistaurin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 2, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) comparing Ruboxistaurin with Placebo (2 arms). Primary endpoints: Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation at 4 weeks, Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation) at 4 weeks and 1 more. Started Dec 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ruboxistaurin
32mg Ruboxistaurin
Placebo
Placebo
03
Endpoints
Primary
Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation
Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation)
Improvement in selective measurements of oxidative stress, endothelial activity and vascular abnormalities which will correlate with PKC activity in the peripheral monocytes
Secondary
Safety of ruboxistaurin
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