Phase Evaluate Fenofibric 110 T2DM 12 II the acid, 135 with months effects of mg, once Diabetic Full fenofibric oral DME acid (SLV348) on placebo changes of DME Phase Evaluate Fenofibrate 1593 T2DM 4 III the 160 mg benefit of tablet, once daily, oral versus placebo both with in limiting the on of DR Pharmacokinetics Studies providing pharmacokinetic data No new information available. Evaluator’s overall conclusions pharmacokinetics No new information available. Pharmacodynamics Studies providing pharmacodynamic data No new information available. Evaluator’s overall conclusions of pharmacodynamics No new information available. Dose selection for the pivotal trials ACCORD-Eye Study: 160mg tablet
Phase II Evaluate the effects of fenofibric acid (SLV348) on changes of DME Fenofibric acid, 135 mg, once oral 110 T2DM with Diabetic DME 12 months Full Phase III Evaluate the benefit of versus placebo both with in limiting the of DR placebo Fenofibrate 160 mg tablet, once daily, oral 1593 T2DM 4 Pharmacokinetics Studies providing pharmacokinetic data No new information available. Evaluator’s overall conclusions pharmacokinetics No new information available. Pharmacodynamics Studies providing pharmacodynamic data No new information available. Evaluator’s overall conclusions of pharmacodynamics No new information available. Dose selection for the pivotal trials ACCORD-Eye Study: 160mg tablet on
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