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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
BioTeSys GmbH
Esslingen am Neckar, Baden Würtemberg, Germany
NOT_YET_RECRUITINGanalyze & realize GmbH
Berlin, Germany
RECRUITINGEndo-PAT RHI value
Change of EndoPAT score RHI measurement Visit 2 to Visit 4. EndoPAT parameter (Reactive Hyperemia Index (RHI) will be assessed per Endo-PAT 2000 according to standardized procedures provided by the manufacturer (Itamar Medical Ltd., Israel), at Visit 2 and Visit 4
Time frame: Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2
EndoPAT Augmentation Index (AI)
Change of EndoPAT parameter Augmentation Index (AI) will be assessed per Endo-PAT 2000 according to standardized procedures provided by the manufacturer (Itamar Medical Ltd., Israel), at Visit 2 and Visit 4
Time frame: Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2
Systolic Blood Pressure
Change in Systolic Blood Pressure after 6 weeks ± 3 Visit 2 versus Visit 3
Time frame: 42 days ± 3
Diastolic Blood Pressure
Change in Diastolic Blood Pressure after 6 weeks ± 3 Visit 2 versus Visit 3
Time frame: 42 days ± 3
Systolic Blood Pressure
Change in Systolic Blood Pressure after 12 weeks ± 6 Visit 2 versus Visit 4
Time frame: 84 weeks ± 6
Diastolic Blood Pressure
Change in Diastolic Blood Pressure after 12 weeks ± 6 Visit 2 versus Visit 4
Time frame: 84 days ± 6
Low Density Lipoprotein cholestorol (LDL-C)
Change in LDL-C concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum LDL-C concentrations.
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Time frame: 42 days ± 3
Low Density Lipoprotein cholestorol (LDL-C)
Change in LDL-C concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum LDL-C concentrations.
Time frame: 84 days ± 6
non-High Density Lipoprotein cholestorol (non-HDL-C)
Change in non-HDL-C concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum non-HDL-C concentrations. The non-HDL cholesterol values are obtained by subtracting the HDL cholesterol value from the total cholesterol.
Time frame: 42 days ± 3
non-High Density Lipoprotein cholestorol (non-HDL-C)
Change in non-HDL-C concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum non-HDL-C concentrations. The non-HDL cholesterol values are obtained by subtracting the HDL cholesterol value from the total cholesterol
Time frame: 84 days ± 6
Total Cholestorol (TC)
Change in TC concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum Total Cholestorol (TC) concentrations.
Time frame: 42 days ± 3
Total Cholestorol (TC)
Change in TC concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum Total Cholestorol (TC) concentrations.
Time frame: 84 days ± 6
High Density Lipoprotein cholestorol (HDL-C)
Change in HDL-C concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum HDL-C concentrations.
Time frame: 42 days ± 3
High Density Lipoprotein cholestorol (HDL-C)
Change in HDL-C concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum HDL-C concentrations.
Time frame: 84 days ± 6
Triglycerides (TG)
Change in TG concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum TG concentrations.
Time frame: 42 days ± 3
Triglycerides (TG)
Change in TG concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum TG concentrations.
Time frame: 84 days ± 6
LDL-C/HDL-C ratio
Change in LDL-C/HDL-C ratio after 6 weeks ± 3 Visit 2 versus Visit 3.
Time frame: 42 days ± 3
LDL-C/HDL-C ratio
Change in LDL-C/HDL-C ratio after 12 weeks ± 6 Visit 2 versus Visit 4.
Time frame: 84 days ± 6
TC/HDL-C ratio
Change in TC/HDL-C ratio after 6 weeks ± 3 Visit 2 versus Visit 3.
Time frame: 42 days ± 3
TC/HDL-C ratio
Change in TC/HDL-C ratio after 12 weeks ± 6 Visit 2 versus Visit 4.
Time frame: 84 days ± 6
SCORE Value
The SCORE value will be assessed on V2 - V4 using the European Low Risk Chart by the European Society of Cardiology (Perk et al., 2012), during biometric assess-ment.
Time frame: 42 days ± 3
SCORE Value
The SCORE value will be assessed on V2 - V4 using the European Low Risk Chart by the European Society of Cardiology (Perk et al., 2012), during biometric assess-ment.
Time frame: 84 days ± 6
Global Evaluation of benefit
Both the subjects and investigator(s) will evaluate independently the benefit of the IP by means of a global scaled evaluation with "very good", "good", "moderate" and "poor".
Time frame: 84 days ± 6