Evaluation of the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and… (NCT03287518) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile
Germany100 participantsStarted 2017-07-28
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female subjects, 40-75 years
✓. BMI 25-34.9 kg/m2
✓. High normal or hypertension grade 1 blood pressure levels (130-159 / 85-99 mmHg) both at screening (mean of the 2nd and 3rd measurement during the assessment in triplicate at V1) and at baseline (mean of the 2nd and 3rd measurement during the assessment in triplicate at V2)
✓. EndoPAT score (RHI): \< 2.2 at V1
✓. Readiness to comply with study procedures, in particular:
✓. Non-smoker / smoking cessation of last ≥12 months prior to V1
✓. Stable body weight in the last 3 months prior to V1 (\<3 kg self-reported change)
✓. If allowed concomitant medications are taken this must have been stable at least during the last month prior to V1
Exclusion criteria
✕. Known allergy or hypersensitivity to the components of the investigational product
✕. Known genetic hyperlipidemia
✕. Known secondary hypertension
✕. Known white-coat hypertension
✕. Known type-1-diabetes
✕
What they're measuring
1
Endo-PAT RHI value
Timeframe: Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2