Trial Outcomes & Findings for A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke (NCT NCT00276380)
NCT ID: NCT00276380
Last Updated: 2019-01-08
Results Overview
The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score\<3 at the end of the study (Day 168) are reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
204 participants
Primary outcome timeframe
Day 168
Results posted on
2019-01-08
Participant Flow
This was a multicentre, international, randomised, double-blind, placebo-controlled study in which 204 subjects were enrolled in 8 centres, distributed in 4 countries: Romania, Poland, Czech Republic and Russian Federation, from 20 February 2003 to 25 February 2009.
The inclusion (baseline) visit on Day 0 was to take place within 3-8 days following an ischaemic stroke.
Participant milestones
| Measure |
EGb761®
Subjects received EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
Placebo
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
88
|
88
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
| Measure |
EGb761®
Subjects received EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
Placebo
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Death
|
5
|
3
|
|
Overall Study
Abnormal aPPT Levels
|
0
|
1
|
Baseline Characteristics
A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
Baseline characteristics by cohort
| Measure |
EGb761®
n=102 Participants
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
Placebo
n=102 Participants
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
69 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 168Population: This analysis was performed on the Intention-To-Treat (ITT) population which includes all subjects having at least one treatment dose.
The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score\<3 at the end of the study (Day 168) are reported.
Outcome measures
| Measure |
EGb761®
n=102 Participants
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=102 Participants
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.
|
59.8 percentage of participants
|
64.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 84Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score\<3 at each follow-up visit (not including end of study) are reported.
Outcome measures
| Measure |
EGb761®
n=102 Participants
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=102 Participants
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.
Day 28
|
31.4 percentage of participants
|
35.3 percentage of participants
|
|
Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.
Day 84
|
46.1 percentage of participants
|
53.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 168Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
The degree of disability and dependence in daily activities was assessed using the modified Rankin scale.The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability,3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The distribution of subjects according to disability severity scores was assessed and the percentage of subjects at each point on the modified Rankin scale are reported for each time point.
Outcome measures
| Measure |
EGb761®
n=102 Participants
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=102 Participants
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 0: No symptoms at all
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 0: No significant disability
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 0: Slight disability
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 0: Moderate disability
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 0: Moderately severe disability
|
74.5 percentage of participants
|
70.6 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 0: Severe disability
|
25.5 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 28: No symptoms at all
|
1.0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 28: No significant disability
|
7.2 percentage of participants
|
9.4 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 28: Slight disability
|
24.7 percentage of participants
|
27.1 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 28: Moderate disability
|
38.1 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 28: Moderately severe disability
|
26.8 percentage of participants
|
27.1 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 28: Severe disability
|
2.1 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 84: No symptoms at all
|
5.4 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 84: No significant disability
|
24.7 percentage of participants
|
25.8 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 84: Slight disability
|
20.4 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 84: Moderate disability
|
38.7 percentage of participants
|
27.0 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 84: Moderately severe disability
|
10.8 percentage of participants
|
13.5 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 84: Severe disability
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 168: No symptoms at all
|
12.5 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 168: No significant disability
|
29.5 percentage of participants
|
31.8 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 168: Slight disability
|
27.3 percentage of participants
|
23.9 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 168: Moderate disability
|
25.0 percentage of participants
|
20.5 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 168: Moderately severe disability
|
5.7 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.
Day 168: Severe disability
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 168Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
The SCAG scale was to be used to evaluate the psychopathological state of the subject. It is composed of 18 symptom areas and an overall global assessment, all rated on a 7-point format from 1=not present to 7=severe. The total score range is from 19 to 133 (best to worst), with a negative mean change from baseline indicating an improvement in symptoms. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.
Outcome measures
| Measure |
EGb761®
n=102 Participants
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=102 Participants
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.
Day 28
|
-7.3 units on a scale
Standard Deviation 5.9
|
-5.0 units on a scale
Standard Deviation 5.3
|
|
Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.
Day 84
|
-8.8 units on a scale
Standard Deviation 8.7
|
-7.1 units on a scale
Standard Deviation 6.6
|
|
Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.
Day 168
|
-11.7 units on a scale
Standard Deviation 8.2
|
-9.2 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Up to Day 168Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
The performance in activities of daily living was assessed by using the Barthel scale. The Barthel scale is an ordinal scale which measures 10 performance items describing activities of daily living. Each item is rated with a given number of points from 0 indicating total dependence up to a maximum of 10 or 15 (depending on performance item) indicating complete independence. The total score range is from 0 to 100 (worst to best), with a positive mean change indicating an improvement in independence. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.
Outcome measures
| Measure |
EGb761®
n=102 Participants
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=102 Participants
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.
Day 28
|
31.2 units on a scale
Standard Deviation 20.3
|
30.6 units on a scale
Standard Deviation 18.6
|
|
Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.
Day 84
|
40.1 units on a scale
Standard Deviation 19.9
|
41.5 units on a scale
Standard Deviation 19.3
|
|
Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.
Day 168
|
46.3 units on a scale
Standard Deviation 20.5
|
45.9 units on a scale
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: Up to Day 168Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
The MMS test was used to evaluate the cognitive function of the subject. It includes tests of orientation, attention, memory, language and visual spatial skills, which are rated with a given number of points assigned to each level or ranking. The lower the score, the more important the mental deficit. The total score range is from 0 to 30 (worst to best), with a positive mean change indicating an improvement (i.e. less mental deficit). Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.
Outcome measures
| Measure |
EGb761®
n=102 Participants
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=102 Participants
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.
Day 28
|
1.2 units on a scale
Standard Deviation 1.9
|
1.2 units on a scale
Standard Deviation 1.6
|
|
Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.
Day 84
|
1.4 units on a scale
Standard Deviation 2.3
|
1.7 units on a scale
Standard Deviation 2.3
|
|
Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.
Day 168
|
1.9 units on a scale
Standard Deviation 2.7
|
2.0 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Up to Day 168Population: This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.
The NIHSS was to be used to objectively quantify the impairment caused by the stroke.The NIHSS is composed of 11 items, each of which score a specific ability between 0 (normal function) and 4 (high level of impairment).The minimum total score is 0 and maximum is 42. Only 8 of the NIHSS subscores were calculated for this study. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. Mean NIHSS subscores for questions 1a (level of consciousness),1b (asking patient the month and their age), and 1c (asking to open and close eyes) were analysed using descriptive quantitative statistics at each visit and the mean change from baseline at each time point is reported. The range for the subscore for items 1a is 0 - 3, for 1b is 0 - 2 and for 1c is 0 - 2 (best to worst), with a negative mean change from baseline indicating an improvement.
Outcome measures
| Measure |
EGb761®
n=102 Participants
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=102 Participants
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168.
Day 28
|
-0.0 units on a scale
Standard Deviation 0.2
|
-0.0 units on a scale
Standard Deviation 0.2
|
|
Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168.
Day 84
|
-0.0 units on a scale
Standard Deviation 0.2
|
-0.0 units on a scale
Standard Deviation 0.1
|
|
Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168.
Day 168
|
-0.0 units on a scale
Standard Deviation 0.2
|
-0.0 units on a scale
Standard Deviation 0.2
|
Adverse Events
EGb761®
Serious events: 12 serious events
Other events: 16 other events
Deaths: 5 deaths
Placebo
Serious events: 7 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
EGb761®
n=101 participants at risk
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=100 participants at risk
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
2/101 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Nervous system disorders
Grand mal convulsion
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Infections and infestations
Cellulitis
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Infections and infestations
Cystitis
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Vascular disorders
Hypertension
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
General disorders
Sudden death
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
Other adverse events
| Measure |
EGb761®
n=101 participants at risk
Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch
|
Placebo
n=100 participants at risk
Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).
The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch.
|
|---|---|---|
|
Infections and infestations
Cystitis
|
2.0%
2/101 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
2.0%
2/100 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Infections and infestations
Pneumonia
|
2.0%
2/101 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Psychiatric disorders
Insomnia
|
5.0%
5/101 • Number of events 5 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
0.00%
0/100 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Psychiatric disorders
Anxiety
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
2.0%
2/100 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
4.0%
4/100 • Number of events 4 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
4/101 • Number of events 4 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
3.0%
3/100 • Number of events 3 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
2.0%
2/100 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Vascular disorders
Hypertension
|
2.0%
2/101 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
2.0%
2/100 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.99%
1/101 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
3.0%
3/100 • Number of events 3 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
2.0%
2/100 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
2/101 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
1.0%
1/100 • Number of events 1 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
3.0%
3/100 • Number of events 3 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/101 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
2.0%
2/100 • Number of events 2 • Up to Day 168
All reported adverse events are treatment emergent adverse events (TEAEs). The analysis population is the Safety population which includes all subjects having received at least one treatment dose and one exploitable safety item after the instauration of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place