Effects of Ginkgo biloba extract EGb 761® on arteriosclerosis-relevant biomarkers in subjects with early stage metabolic syndrome
| ISRCTN | ISRCTN69953971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69953971 |
| Secondary identifying numbers | 523006.01.009 |
- Submission date
- 23/11/2010
- Registration date
- 14/01/2011
- Last edited
- 13/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F.A. Malek
Scientific
Scientific
Dr. Willmar Schwabe GmbH & Co. KG
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
Study information
| Study design | Phase I/IIA, single-centre, open trial with a within-subject comparison of diverse atherothrombotic risk markers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a copy of subject information form |
| Scientific title | 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 |
| Study objectives | To evaluate the pharmacodynamic effects, safety and tolerability of a 6-month treatment with 120 mg twice daily Ginkgo biloba extract EGb 761® after a 1-month placebo run-in phase in subjects with early stage metabolic syndrome with regard to biochemical atherothrombotic risk markers and factors. On 18/09/2012 the anticipated end date was changed from 31/12/2011 to 31/12/2013. On 13/12/2013 the anticipated end date was changed from 31/12/2013 to 31/12/2014. |
| Ethics approval(s) | Ethics Committee UMHAT "St. Ivan Rilski" EAD, 16/12/2010, ref: 38/16.12.2010 |
| Health condition(s) or problem(s) studied | Early stage metabolic syndrome |
| Intervention | 120 mg EGb 761® film coated tablets orally (p.o.) twice daily for 6 months after a one month single-blind run-in phase for eligibility assessment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Ginkgo biloba extract (EGb 761®) |
| Primary outcome measure | 1. Effects on diverse athero-thrombotic risk markers and factors after 6 months of investigational treatment (additionally selected biomarkers at screening, on baseline, after 1, 2, 4 and 6 months of investigational treatment) 2. Effects on mood state (Multidimensional Mood State Questionnaire [MDMQ] on baseline and after 2 and 6 months of investigational treatment) 3. Clinical safety and tolerability (adverse events, vital functions and clinical laboratory tests at each visit, ECG at screening, on baseline and after 6 months of investigational treatment) |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 15/01/2011 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Run-in-phase: 30 subjects; Active treatment phase: at least 24 subjects |
| Key inclusion criteria | 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 6. Absence of confounding co-medication 7. Willing and able to provide informed consent 8. Willing and able to comply with all procedures of the trial and attend all scheduled visits at the investigational site |
| Key exclusion criteria | 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 9.2. ECG: QTc greater than or equal to 450 msec (acc. Fridericia), QRS greater than or equal to 100 msec, PQ greater than or equal to 200 msec 9.3. Subjects with cardiac pacemaker or implantable cardioverter defibrillator 10. Relevant adverse clinical laboratory finding except for those explained and/or compatible with early-stage metabolic syndrome, in particular (but not exclusively) haemoglobin less than 13 g/dl for men and less than 12 g/dl for women; liver enzymes greater than 1.5 the upper limit of the normal range 11. Positive results for hepatitis and human immunodeficiency virus (HIV) serology 12. Positive alcohol or drug test 13. Use of prohibited medications, in particular medications for the treatment of hypertension, coronary heart disease, cardiac insufficiency, dysrhythmia, diabetes, hyper- or dyslipidaemia, anti-coagulants; such medications should not have been used within the two months before visit 1 and during the trial 14. Use (within the last two months before visit 1) of prohibited food supplements that might confound to the study criteria 15. Donation of blood or plasma within the last 30 days before visit 1 16. Evidence or suspicion that the subject is (socially) drug dependent, including those drinking more than 40 g alcohol per day 17. Smoking more than 10 cigarettes per day 18. Adherence to a prohibited diet (e.g. vegetarian) or lifestyle (including extreme physical activities such as competitive sports and weight lifting) 19. Evidence or suspicion that the subject might not be willing or able to comply with the study directives and restrictions, or that the subject might not be sufficiently reliable and trustworthy 20. Subjects who are known or suspected not to be capable of understanding and evaluation the information that is given to them as part of the obligatory information policy (informed consent), in particular regarding the risks and discomfort due to trial procedure to which they would agree to be exposed |
| Date of first enrolment | 15/01/2011 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Bulgaria
- Germany
Study participating centre
Dr. Willmar Schwabe GmbH & Co. KG
Karlsruhe
76227
Germany
76227
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
c/o F. A. Malek, MD, PhD
Clinical Research Department
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
| Website | http://www.schwabepharma.com/international/ |
|---|---|
"ROR" |
https://ror.org/043rrkc78 |
Funders
Funder type
Industry
Dr Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
