An interventional study of IQP-AS-118 and Placebo in Blood Flow and Cardiovascular Disease, sponsored by InQpharm Group. Withdrawn at 1 site in Germany. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by InQpharm Group · Not applicable, Interventional, and Treatment
The main objective of this study is to evaluate the benefit of IQP-AS-118 on the vasoactive effects in healthy subjects.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
Browse Cardiovascular Diseases studies →InQpharm Group is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Blood pressure (BP) at screening:
Readiness to comply with study procedures, in particular:
Exclusion Criteria:
History and/or presence of clinically significant cardiovascular disease as per investigator's judgement:
Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:
To be taken once daily dosing of 1 tablet in the morning with 250 mL of water. The tablets should not be chewed, but swallowed whole.
Dietary Supplement: IQP-AS-118
To be taken once daily dosing of 1 tablet in the morning with 250 mL of water. The tablets should not be chewed, but swallowed whole.
Dietary Supplement: Placebo
1 tablet in the morning
1 tablet in the morning
Change in EndoPAT (chronic effect)
Pre-dose at the end vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Change in EndoPAT (acute effect)
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in ex vivo blood platelet aggregation / adhesion (acute effect)
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in ex vivo blood platelet aggregation / adhesion pre-dose (chronic effect)
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in blood coagulation / clotting parameters (acute effect)
3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in blood coagulation / clotting parameters predose (chronic effect)
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Global evaluation of benefit
Assessed by the subjects and investigator at end of each intervention (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Changes in SF- 12
End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Physical examination
End of each intervention vs. screening (Week 4 vs. screening, week 12 vs. screening) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Pulse rate
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Systolic Blood Pressure
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Diastolic Blood Pressure
End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Assessment of Adverse Events
Start and end of each intervention (Week 0, week 4, week 8 and week 12) (inclusive of 4 weeks of wash-out period)
Time frame: 12 weeks
Global assessment of tolerability
Assessed by the subjects and investigator (4-point categorical scale) at week 4 and week 12
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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InQpharm Group