Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT03287518
Status:
UNKNOWN
Last Update Posted:
2017-11-09
First Post:
2017-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile
Sponsor:
Analyze & Realize
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: