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Effects and safety of Korodin Herz-Kreislauf-Tropfen on moderate hypotension and influence on cognitive functions in adults

Phase 1
Conditions
moderate low blood pressure
Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
Registration Number
EUCTR2017-003264-13-DE
Lead Sponsor
Robugen GmbH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
120
Inclusion Criteria

moderate low blood pressure
Subjects must have moderate low blood pressure but be otherwise healthy as judged on the Basis of a medical examination
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

no low blood pressure
other medications, alcohol
if female: pregnancy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: ;Secondary Objective: ;Primary end point(s): Change of moderate low blood pressure;Timepoint(s) of evaluation of this end point: Change of moderate low blood pressure<br>before - meanwhile and after Trial - 1,3,7,15 minutes after oral intake
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): Change of cognitive and mental functions;Timepoint(s) of evaluation of this end point: immediately after trial 15 and 30 minutes
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