The main objective of this double-blind, randomised, placebo-controlled study is to assess the benefit and tolerability of Arterin Cholesterol in subjects with elevated lipid levels within a 12-week period of use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
114
240mg active ingredient daily
120mg active ingredient daily
Placebo tablet
analyze & realize GmbH
Berlin, Germany
RECRUITINGLDL-C levels between High Dose IP and placebo
Difference in LDL-C levels between High Dose IP and placebo at study end compared to baseline
Time frame: 12 weeks
Difference LDL-C levels between Low Dose IP and placebo
Difference in change of LDL-C levels between Low Dose IP and placebo at study end compared to baseline
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in LDL-C levels at V3, V4 and V5 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in change in LDL-C levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in TC levels at V3, V4 and V5 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in change in TC levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in TG levels at V3, V4 and V5 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
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Difference in change in TG levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in HDL-C levels at V3, V4 and V5 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in change in HDL-C levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in LDL-C/HDL-C ratio at V3, V4 and V5 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in change in LDL-C/HDL-C ratio at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in SCORE value at V3, V4 and V5 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in change in SCORE value at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Difference in global evaluation of benefit by the subject and investigator at study end between combined IP vs. placebo
Time frame: 12 weeks