An explorative clinical trial to investigate the effects of Ginkgo biloba extract EGb 761® on arteriosclerosis-relevant biomarkers in men and women with early stage metabolic syndrome

Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 sites30 target enrollmentJanuary 14, 2011

Overview

No summary available.

Registry

who.int

Start Date

January 14, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

•1\. Male and female Caucasian subjects; females are eligible for enrolment if non\-pregnant, non\-lactating, having a negative pregnancy test at VI\-01 and VI\-02\+, post\-menopausal or using medically adequate contraception
•2\. Aged 21 to 50 years (boundaries included)
•3\. Lipoprotein(a) fraction: Lp(a) greater than 25 mg/dL at VI\-01 and VI\-02
•4\. Early stage metabolic syndrome \- at least two but not more than three of the criteria listed below at VI\-01 and VI\-02:
•4\.1\. Waist circumference greater than or equal to 102 cm in men, greater than or equal to 88 cm in women
•4\.2\. Morning fasting triglyceride levels greater than or equal to 150 mg/dL (1\.70 mmol/L)
•4\.3\. Morning fasting high density lipoprotein (HDL)\-cholesterol less than 40 mg/dL (1\.04 mmol/L) in men, less than 50 mg/dL (1\.30 mmol/L) in women
•4\.4\. Recumbent systolic blood pressure (SBP) greater than or equal to 130 mmHg or diastolic blood pressure (DBP) greater than 85 mmHg
•4\.5\. Morning fasting glucose greater than or equal to 100 mg/dL (5\.55 mmol/L)
•5\. Absence of confounding co\-morbidity

•1\. Previous participation in the trial
•2\. Participation in another clinical trial with a registered or non\-registered drug or food supplement within the last 3 months prior to entry into the present study
•3\. Evidence or suspicion of hypersensitivity to the investigational drug
•4\. History or presence of treatment demanding allergies (including drug allergies)
•5\. Presence of acute or chronic infection at the time of recruitment
•6\. Evidence or suspicion of any relevant congenital disease or abnormality
•7\. Evidence or suspicion of any relevant clinical abnormality (as based on medical history, physical examination, vital signs, and 12\-lead electrocardiogram \[ECG])
•8\. Known gastrointestinal disorders (e.g. gastro\-oesophageal reflux, partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea) within the last 6 months prior to inclusion into the study
•9\. Limiting vital signs, in particular:
•9\.1\. Resting recumbent heart rate less than 50 or greater than 90 bpm