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Clinical Trial Summary

The main objective of the study is to evaluate the endothelial function of WAK2017. In addition the effects on the blood pressure and the parameters of lipid metabolism will be explored.


Clinical Trial Description

The main objective of the study is to evaluate the endothelial function of WAK2017. In addition the effects on the blood pressure and the parameters of lipid metabolism will be explored.

Primary endpoint is defined as the difference in change in EndoPAT score RHI pre-dose and after 12 weeks of IP intake (visit V4 vs. V2) in comparison between the verum and placebo.

To characterize the benefit of the IP the following secondary endpoints will be analysed in comparison be-tween the verum and placebo:

- EndoPAT AI at V4 vs. V2

- SBP at V3, V4 vs. V2, respectively

- DBP at V3, V4 vs. V2, respectively

- Fasting LDL-C concentrations and non-HDL-C at V3, V4 vs. V2, respectively

- Fasting TC concentrations at V3, V4 vs. V2, respec-tively

- Fasting HDL-C concentrations at V3, V4 vs. V2, respectively

- Fasting TG concentrations at V3, V4 vs. V2, respectively

- Fasting LDL-C/HDL-C and TC/HDL-C ratio at V3, V4 vs. V2, respectively

- SCORE value at V3, V4 vs. V2, respectively

- Global evaluation of benefit by the subjects/ investigator at V4 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03287518
Study type Interventional
Source Analyze & Realize
Contact Maya Ulbricht
Phone 0049 3040 00 8
Email mulbricht@a-r.com
Status Recruiting
Phase N/A
Start date July 28, 2017
Completion date September 15, 2018

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