Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT03287518
Brief 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.
Detailed 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:
NCT03287518
Study Brief:
Protocol Section:
NCT03287518