Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke (NCT NCT03815292)
NCT ID: NCT03815292
Last Updated: 2021-02-23
Results Overview
MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
276 participants
Primary outcome timeframe
24 weeks of the treatment as compared to the baseline
Results posted on
2021-02-23
Participant Flow
In total, 276 patients signed informed consent. After screening procedures, data from 1 patient did not meet the inclusion / exclusion criteria. The study randomized 275 patients.
Participant milestones
| Measure |
MMH-MAP
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
140
|
|
Overall Study
COMPLETED
|
135
|
140
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MMH-MAP
n=135 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=140 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
Total
n=275 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 7.7 • n=135 Participants
|
63.5 years
STANDARD_DEVIATION 8.5 • n=140 Participants
|
64.0 years
STANDARD_DEVIATION 8.1 • n=275 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=135 Participants
|
62 Participants
n=140 Participants
|
124 Participants
n=275 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=135 Participants
|
78 Participants
n=140 Participants
|
151 Participants
n=275 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
135 participants
n=135 Participants
|
140 participants
n=140 Participants
|
275 participants
n=275 Participants
|
PRIMARY outcome
Timeframe: 24 weeks of the treatment as compared to the baselineMoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Outcome measures
| Measure |
MMH-MAP
n=135 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=140 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More)
|
124 Participants
|
115 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeks of the treatment as compared to the baselineMoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Outcome measures
| Measure |
MMH-MAP
n=135 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=140 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Change in MoCA (The Montreal Cognitive Assessment Test) Score
∆ between baseline and after 24 weeks
|
3.8 score on a scale
Standard Deviation 2.4
|
3.1 score on a scale
Standard Deviation 2.9
|
|
Change in MoCA (The Montreal Cognitive Assessment Test) Score
Baseline
|
19.4 score on a scale
Standard Deviation 2.3
|
19.2 score on a scale
Standard Deviation 2.5
|
|
Change in MoCA (The Montreal Cognitive Assessment Test) Score
After 24 weeks
|
23.3 score on a scale
Standard Deviation 2.7
|
22.5 score on a scale
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeks of the treatment as compared to the baselinePopulation: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.
Outcome measures
| Measure |
MMH-MAP
n=131 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=127 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Percentage of Patients With Improved Performance in Activities of Daily Living (Barthel Index Score of the Baseline + 5 or More)
|
118 Participants
|
102 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeks of the treatment as compared to the baselineScale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.
Outcome measures
| Measure |
MMH-MAP
n=135 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=140 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Change in Barthel Index Score
Baseline
|
74.7 score on a scale
Standard Deviation 5.4
|
74.8 score on a scale
Standard Deviation 5.7
|
|
Change in Barthel Index Score
After 24 weeks
|
89.7 score on a scale
Standard Deviation 8.7
|
86.6 score on a scale
Standard Deviation 11.3
|
|
Change in Barthel Index Score
∆ between baseline and after 24 weeks
|
14.9 score on a scale
Standard Deviation 8.8
|
12.2 score on a scale
Standard Deviation 10.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeks of the treatment as compared to the baselineScale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains. Each domain consists of 3 to 10 items that are averaged to generate an overall score. Total score minimum value is 1 and maximum value is 245. Higher values represent a better outcome.
Outcome measures
| Measure |
MMH-MAP
n=135 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=140 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score
Baseline
|
155.6 score on a scale
Standard Deviation 33.0
|
156.6 score on a scale
Standard Deviation 32.6
|
|
Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score
After 24 weeks
|
184.2 score on a scale
Standard Deviation 35.3
|
173.7 score on a scale
Standard Deviation 38.0
|
|
Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score
∆ between baseline and after 24 weeks
|
27.9 score on a scale
Standard Deviation 26.1
|
17.5 score on a scale
Standard Deviation 26.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeks of the treatmentPopulation: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
Rating scale for assessment of the therapeutic effect of treatment and associated side effects. The scale consists of 2 items: therapeutic effect and side effects. Scores in therapeutic effect range from 1 (marked improvement) to 13 (unchanged or worse). Scores in side effects range from 0 (no side effects) to 3 (side effects outweigh therapeutic effects). Efficacy index ranges between 0 and 16. Higher values represent a worse result.
Outcome measures
| Measure |
MMH-MAP
n=131 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=127 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
The CGI-EI (Clinical Global Impression Efficacy Index) Score
Therapeutic effect
|
5.7 score on a scale
Standard Deviation 3.3
|
6.9 score on a scale
Standard Deviation 3.4
|
|
The CGI-EI (Clinical Global Impression Efficacy Index) Score
Side effects
|
0.1 score on a scale
Standard Deviation 0.4
|
0.1 score on a scale
Standard Deviation 0.4
|
|
The CGI-EI (Clinical Global Impression Efficacy Index) Score
Efficacy index
|
5.8 score on a scale
Standard Deviation 3.4
|
7.0 score on a scale
Standard Deviation 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 and 28 weeks of the studyPopulation: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
Test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Outcome measures
| Measure |
MMH-MAP
n=131 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=127 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up
After 24 weeks
|
23.3 score on a scale
Standard Deviation 2.7
|
22.5 score on a scale
Standard Deviation 3.0
|
|
Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up
After 28 weeks
|
23.6 score on a scale
Standard Deviation 3.1
|
22.7 score on a scale
Standard Deviation 3.1
|
|
Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up
∆ between 24 and 28 weeks
|
0.4 score on a scale
Standard Deviation 1.3
|
0.3 score on a scale
Standard Deviation 1.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 and 28 weeks of the studyPopulation: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
Scale for measurement of performance in activities of daily living (ADL). The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.
Outcome measures
| Measure |
MMH-MAP
n=131 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=127 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Change in Barthel Index Score During Follow-up
After 24 weeks
|
89.7 score on a scale
Standard Deviation 8.7
|
86.6 score on a scale
Standard Deviation 11.3
|
|
Change in Barthel Index Score During Follow-up
After 28 weeks
|
90.6 score on a scale
Standard Deviation 10.9
|
87.4 score on a scale
Standard Deviation 10.1
|
|
Change in Barthel Index Score During Follow-up
∆ between 24 and 28 weeks
|
1.5 score on a scale
Standard Deviation 3.1
|
0.6 score on a scale
Standard Deviation 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 and 28 weeks of the studyPopulation: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains.Each domain consists of 3 to 10 items that are averaged to generate an overall score.Total score minimum value is 1 and maximum value is 245.Higher values represent a better outcome.
Outcome measures
| Measure |
MMH-MAP
n=131 Participants
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=127 Participants
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up
After 24 weeks
|
184.2 score on a scale
Standard Deviation 35.3
|
173.7 score on a scale
Standard Deviation 38.0
|
|
Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up
After 28 weeks
|
187.8 score on a scale
Standard Deviation 37.7
|
174.7 score on a scale
Standard Deviation 38.0
|
|
Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up
∆ between 24 and 28 weeks
|
4.1 score on a scale
Standard Deviation 9.5
|
2.8 score on a scale
Standard Deviation 10.2
|
Adverse Events
MMH-MAP
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MMH-MAP
n=135 participants at risk
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=140 participants at risk
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Vascular disorders
Limb vein thrombosis
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Nervous system disorders
Cerebral infarction
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Infections and infestations
Nosocomial pneumonia
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
General disorders
Acute coronary syndrome
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Nervous system disorders
Recurrent stroke
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
Other adverse events
| Measure |
MMH-MAP
n=135 participants at risk
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration
|
Placebo
n=140 participants at risk
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration
|
|---|---|---|
|
Gastrointestinal disorders
Acute abdomen
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Pain in the upper abdomen
|
0.00%
0/135 • During the study - 28 weeks.
|
1.4%
2/140 • Number of events 2 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/135 • During the study - 28 weeks.
|
1.4%
2/140 • Number of events 2 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Infections and infestations
Bronchitis
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
4/135 • Number of events 4 • During the study - 28 weeks.
|
5.0%
7/140 • Number of events 7 • During the study - 28 weeks.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Infections and infestations
Pneumonia
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Infections and infestations
Tonsillitis
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Itchy rash
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Limb pain
|
1.5%
2/135 • Number of events 2 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Nervous system disorders
Headache
|
5.9%
8/135 • Number of events 8 • During the study - 28 weeks.
|
2.9%
4/140 • Number of events 4 • During the study - 28 weeks.
|
|
Nervous system disorders
Dizziness
|
2.2%
3/135 • Number of events 3 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Nervous system disorders
Cognitive impairment
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Nervous system disorders
Memory disorder
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/135 • During the study - 28 weeks.
|
1.4%
2/140 • Number of events 2 • During the study - 28 weeks.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Nervous system disorders
Somnolence
|
3.0%
4/135 • Number of events 4 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Nervous system disorders
Cerebral infarction
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
1.4%
2/140 • Number of events 2 • During the study - 28 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Hepatobiliary disorders
Liver steatosis
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Cardiac disorders
Heartbeat
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Cardiac disorders
Tachycardia
|
1.5%
2/135 • Number of events 2 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Vascular disorders
Hypertension
|
1.5%
2/135 • Number of events 2 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
2.2%
3/135 • Number of events 3 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Investigations
Protein in urine
|
0.00%
0/135 • During the study - 28 weeks.
|
1.4%
2/140 • Number of events 2 • During the study - 28 weeks.
|
|
Investigations
Oxalates in urine
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Investigations
Abnormal urine test results
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Investigations
Increased blood pressure
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Investigations
Increased liver enzyme levels
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Investigations
Blood pressure decrease
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Investigations
Weight gain
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
General disorders
Asthenia
|
2.2%
3/135 • Number of events 3 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
General disorders
Hunger
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Psychiatric disorders
Affective lability
|
0.00%
0/135 • During the study - 28 weeks.
|
1.4%
2/140 • Number of events 2 • During the study - 28 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Psychiatric disorders
Increased libido
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Psychiatric disorders
Low mood
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Psychiatric disorders
Sense of anxiety
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Injury, poisoning and procedural complications
Hematoma due to trauma
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/135 • During the study - 28 weeks.
|
0.71%
1/140 • Number of events 1 • During the study - 28 weeks.
|
|
Vascular disorders
Limb vein thrombosis
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.74%
1/135 • Number of events 1 • During the study - 28 weeks.
|
0.00%
0/140 • During the study - 28 weeks.
|
Additional Information
Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
MATERIA MEDICA HOLDING
Phone: +74952761571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place