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A Phase III, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study, Evaluating the Safety, Tolerability and Efficacy of RO4607381 by Measuring Flow Mediated Dilatation in the Brachial Arter...

Update Il y a 4 ans
Reference: EUCTR2007-003406-10

A Phase III, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study, Evaluating the Safety, Tolerability and Efficacy of RO4607381 by Measuring Flow Mediated Dilatation in the Brachial Artery, 24 hour Ambulatory Blood Pressure, Lipids, Lipoproteins and Markers Vascular Inflammation, Oxidation and CV risk in Patients with Coronary Heart Disease (CHD) or CHD Risk Equivalents

Woman and Man

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Extract

The primary efficacy objective of this study is to evaluate the effect of RO4607381 on endothelial function as measured by flow mediated dilatation (FMD) of the brachial artery in patients with CHD or CHD risk equivalents at 12 weeks. The primary safety objective of this study is to evaluate the effect of RO4607381 on blood pressure as measured by 24 hour ambulatory blood pressure monitoring (ABPM) at 4 weeks.

Inclusion criteria

  • Patients with Coronary Heart Disease (CHD) or CHD Risk Equivalents

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