Blood Pressure Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile
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.
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
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