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Trial record 22 of 1900 for:    Diseases | ( Map: Puerto Rico )

A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00838110
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : February 8, 2013
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Dimebon
Drug: Placebo
Enrollment 742
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dimebon (Cohort 1) Placebo (Cohort 1) Dimebon (Cohort 2) Placebo (Cohort 2)
Hide Arm/Group Description Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26. Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26. Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12. Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
Period Title: Overall Study
Started 127 128 243 244
Treated 127 127 243 244
Completed 105 106 226 226
Not Completed 22 22 17 18
Reason Not Completed
Death             0             0             1             2
Adverse Event             11             10             8             7
Withdrawal by Subject             5             6             3             4
Other             3             3             3             2
Protocol Violation             0             2             1             1
Lost to Follow-up             3             0             0             0
Did not meet eligibility criteria             0             0             1             2
Randomized but not treated             0             1             0             0
Arm/Group Title Dimebon Placebo Total
Hide Arm/Group Description Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2. Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2. Total of all reporting groups
Overall Number of Baseline Participants 370 371 741
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 371 participants 741 participants
50 to 59 years 24 13 37
60 to 69 years 50 63 113
70 to 79 years 155 154 309
80 to 85 years 109 103 212
Greater than 85 years 32 38 70
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 370 participants 371 participants 741 participants
Female
192
  51.9%
198
  53.4%
390
  52.6%
Male
178
  48.1%
173
  46.6%
351
  47.4%
1.Primary Outcome
Title Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Hide Description Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).
Time Frame Baseline up to Week 30 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 1 analysis set included all those participants in the safety analysis set (SAS) (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Arm/Group Title Dimebon (Cohort 1) Placebo (Cohort 1)
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
Overall Number of Participants Analyzed 127 127
Measure Type: Number
Unit of Measure: percentage of participants
Systolic BP (<90 mmHg) (n=127,127) 0.8 1.6
Increase in systolic BP (>=30 mmHg) (n=126,124) 9.5 10.5
Decrease in systolic BP (>=30 mmHg) (n=126,124) 16.7 12.9
Diastolic BP (<50 mmHg) (n=127,127) 0.8 1.6
Increase in diastolic BP (>=20 mmHg) (n=126,124) 7.1 7.3
Decrease in diastolic BP (>=20 mmHg) (n=126,124) 15.9 12.9
Heart rate (>120 bpm) (n=127,127) 0.0 0.0
2.Primary Outcome
Title Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Hide Description Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.
Time Frame Baseline up to Week 16 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 2 analysis set included all those participants in the SAS (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Arm/Group Title Dimebon (Cohort 2) Placebo (Cohort 2)
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
Overall Number of Participants Analyzed 243 244
Measure Type: Number
Unit of Measure: percentage of participants
Systolic BP (<90 mmHg) (n=243,244) 0.8 0.0
Increase in systolic BP (>=30 mmHg) (n=240,240) 3.8 8.3
Decrease in systolic BP (>=30 mmHg) (n=240,240) 9.6 8.8
Diastolic BP (<50 mmHg) (n=243,244) 1.2 0.8
Increase in diastolic BP (>=20 mmHg) (n=240,240) 6.3 5.4
Decrease in diastolic BP (>=20 mmHg) (n=240,240) 6.7 7.5
Heart rate (>120 bpm) (n=243,244) 0.0 0.0
3.Primary Outcome
Title Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
Hide Description Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia’s formula (QTcF interval).
Time Frame Baseline up to Week 30 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Arm/Group Title Dimebon (Cohort 1) Placebo (Cohort 1)
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
Overall Number of Participants Analyzed 127 127
Measure Type: Number
Unit of Measure: percentage of participants
PR int (>=300 msec) (n=123,113) 0.0 0.0
Increase in PR int (>=25/50%) (n=122,112) 0.0 0.0
QRS int (>=200 msec) (n=127,127) 0.0 0.0
Increase in QRS int (>=25/50%) (n=126,126) 1.6 0.0
QT int (>=500 msec) (n=127,127) 0.0 2.4
QTcF int (450 to <480 msec) (n=127,127) 15.7 13.4
QTcF int (480 to <500 msec) (n=127,127) 1.6 4.7
QTcF int (>=500 msec) (n=127,127) 0.0 0.8
Increase in QTcF int (>=30 to <60msec )(n=126,126) 9.5 7.1
Increase in QTcF int (>=60 msec) (n=126,126) 0.8 0.0
4.Primary Outcome
Title Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
Hide Description Abnormal ECG findings included maximum value of >=300 msec, maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval; maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia’s formula (QTcF interval).
Time Frame Baseline up to Week 16 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Arm/Group Title Dimebon (Cohort 2) Placebo (Cohort 2)
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg Dimebon (latrepirdine) tablet orally three times a day up to Week 12.
Overall Number of Participants Analyzed 243 244
Measure Type: Number
Unit of Measure: percentage of participants
PR int (>=300 msec) (n=232,232) 0.9 0.0
Increase in PR int (>=25/50%) (n=231,229) 0.0 0.0
QRS int (>=200 msec) (n=243,244) 0.0 0.0
Increase in QRS int (>=25/50%) (n=242,243) 0.8 0.4
QT int (>=500 msec) (n=243,244) 0.8 0.8
QTcF int (450 to <480 msec) (n=243,244) 15.6 19.3
QTcF int (480 to <500 msec) (n=243,244) 2.1 0.8
QTcF int (>=500 msec) (n=243,244) 1.2 0.0
Increase in QTcF int (>=30 to <60 msec)(n=242,243) 6.6 5.8
Increase in QTcF int (>=60 msec) (n=242,243) 0.4 0.0
5.Primary Outcome
Title Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Hide Description For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.
Time Frame Baseline up to Week 30 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 1 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Arm/Group Title Dimebon (Cohort 1) Placebo (Cohort 1)
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
Overall Number of Participants Analyzed 126 124
Measure Type: Number
Unit of Measure: percentage of participants
Hemoglobin (<0.8*LLN) (n=126,123) 1 1
Red blood cell count (<0.8*LLN) (n=126,123) 2 0
Mean corpuscular volume (<0.9*LLN) (n=126,123) 0 2
Mean corpuscular volume (>1.1*ULN) (n=126,123) 0 0
White blood cell count (<0.6*LLN) (n=126,123) 0 1
White blood cell count (>1.5*ULN) (n=126,123) 1 0
Lymphocytes (<0.8*LLN) (n=126,123) 2 1
Lymphocytes (>1.2*ULN) (n=126,123) 1 2
Total Neutrophils (<0.8*LLN) (n=126,123) 0 1
Total Neutrophils (>1.2*ULN) (n=126,123) 4 3
Monocytes (>1.2*ULN) (n=126,123) 0 1
Total bilirubin (>1.5*ULN) (n=125,123) 1 2
Aspartate aminotransferase (>3.0*ULN) (n=125,123) 1 0
Alanine aminotransferase (>3.0*ULN) (n=125,123) 1 1
Blood urea nitrogen (>1.3*ULN) (n=125,123) 1 2
Creatinine (>1.3*ULN) (n=125,123) 2 0
Sodium (<0.95*LLN) (n=125,123) 0 1
Sodium (>1.05*ULN) (n=125,123) 0 1
Potassium (<0.9*LLN) (n=125,123) 0 2
Potassium (>1.1*ULN) (n=125,123) 2 1
Calcium (>1.1*ULN) (n=125,123) 1 0
Magnesium (<0.9*LLN) (n=125,123) 0 0
Magnesium (>1.1*ULN) (n=125,123) 20 24
Phosphate (<0.8*LLN) (n=125,123) 0 0
Phosphate (>1.2*ULN) (n=125,123) 0 0
Bicarbonate (<0.9*LLN) (n=125,123) 2 0
Bicarbonate (>1.1*ULN) (n=125,123) 0 1
Glucose (>1.5*ULN) (n=125,123) 9 10
Creatine kinase (>2.0*ULN) (n=125,123) 3 2
Urine specific gravity (<1.003) (n=125,123) 0 0
Urine specific gravity (>1.030) (n=125,123) 2 2
Urine pH (>8) (n=125,123) 0 1
Urine glucose (>=1) (n=125,123) 4 3
Urine ketones (>=1) (n=125,123) 1 2
Urine blood (>=1) (n=125,123) 32 7
Urine protein (>=1) (n=125,123) 4 2
6.Primary Outcome
Title Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Hide Description For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.
Time Frame Baseline up to Week 16 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 2 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.
Arm/Group Title Dimebon (Cohort 2) Placebo (Cohort 2)
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
Overall Number of Participants Analyzed 239 241
Measure Type: Number
Unit of Measure: percentage of participants
Hemoglobin (<0.8*LLN) (n=239,241) 0 0
Red blood cell count (<0.8*LLN) (n=239,241) 0 0
Mean corpuscular volume (<0.9*LLN) (n=239,241) 0 0
Mean corpuscular volume (>1.1*ULN) (n=239,241) 0 0
White blood cell count (<0.6*LLN) (n=239,241) 0 0
White blood cell count (>1.5*ULN) (n=239,241) 0 0
Lymphocytes (<0.8*LLN) (n=239,241) 1 0
Lymphocytes (>1.2*ULN) (n=239,241) 3 0
Total Neutrophils (<0.8*LLN) (n=239,241) 0 1
Total Neutrophils (>1.2*ULN) (n=239,241) 2 1
Monocytes (>1.2*ULN) (n=239,241) 0 0
Total bilirubin (>1.5*ULN) (n=239,241) 0 0
Aspartate aminotransferase (>3.0*ULN) (n=239,241) 0 0
Alanine aminotransferase (>3.0*ULN) (n=239,241) 0 0
Blood urea nitrogen (>1.3*ULN) ((n=239,241) 0 0
Creatinine (>1.3*ULN) (n=239,241) 0 1
Sodium (<0.95*LLN) (n=239,241) 0 0
Sodium (>1.05*ULN) (n=239,241) 0 0
Potassium (<0.9*LLN) (n=239,241) 0 0
Potassium (>1.1*ULN) (n=239,241) 0 0
Calcium (>1.1*ULN) (n=239,241) 0 0
Magnesium (<0.9*LLN) (n=239,241) 0 0
Magnesium (>1.1*ULN) (n=239,241) 18 17
Phosphate (<0.8*LLN) (n=239,241) 0 0
Phosphate (>1.2*ULN) (n=239,241) 0 0
Bicarbonate (<0.9*LLN) (n=239,241) 0 0
Bicarbonate (>1.1*ULN) (n=239,241) 0 0
Glucose (>1.5*ULN) (n=239,241) 6 4
Creatine kinase (>2.0*ULN) (n=239,241) 3 1
Urine specific gravity (<1.003) (n=237,240) 0 0
Urine specific gravity (>1.030) (n=237,240) 2 1
Urine pH (>8) (n=237,240) 0 0
Urine glucose (>=1) (n=237,240) 3 3
Urine ketones (>=1) (n=237,240) 0 0
Urine blood (>=1) (n=237,240) 26 5
Urine protein (>=1) (n=237,240) 1 3
7.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs) in Cohort 1
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame Baseline up to Week 30 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study.
Arm/Group Title Dimebon (Cohort 1) Placebo (Cohort 1)
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
Overall Number of Participants Analyzed 127 127
Measure Type: Number
Unit of Measure: percentage of participants
64.6 64.6
8.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs) in Cohort 2
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame Baseline up to Week 16 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study.
Arm/Group Title Dimebon (Cohort 2) Placebo (Cohort 2)
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
Overall Number of Participants Analyzed 243 244
Measure Type: Number
Unit of Measure: percentage of participants
55.1 53.3
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Dimebon Placebo
Hide Arm/Group Description Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2. Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
All-Cause Mortality
Dimebon Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dimebon Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   26/370 (7.03%)   28/371 (7.55%) 
Blood and lymphatic system disorders     
Pancytopenia * 1  1/370 (0.27%)  0/371 (0.00%) 
Thrombotic thrombocytopenic purpura * 1  1/370 (0.27%)  0/371 (0.00%) 
Cardiac disorders     
Atrioventricular block complete * 1  0/370 (0.00%)  1/371 (0.27%) 
Bradycardia * 1  0/370 (0.00%)  1/371 (0.27%) 
Cardiac failure congestive * 1  0/370 (0.00%)  1/371 (0.27%) 
Myocardial infarction * 1  0/370 (0.00%)  2/371 (0.54%) 
Sick sinus syndrome * 1  1/370 (0.27%)  0/371 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/370 (0.27%)  1/371 (0.27%) 
Colitis * 1  0/370 (0.00%)  1/371 (0.27%) 
Colitis ulcerative * 1  1/370 (0.27%)  0/371 (0.00%) 
Diverticulum intestinal haemorrhagic * 1  0/370 (0.00%)  1/371 (0.27%) 
Dysphagia * 1  0/370 (0.00%)  1/371 (0.27%) 
Haematochezia * 1  0/370 (0.00%)  1/371 (0.27%) 
General disorders     
Asthenia * 1  1/370 (0.27%)  0/371 (0.00%) 
Chest discomfort * 1  1/370 (0.27%)  0/371 (0.00%) 
Chest pain * 1  3/370 (0.81%)  0/371 (0.00%) 
Infections and infestations     
Bronchitis * 1  1/370 (0.27%)  0/371 (0.00%) 
Diverticulitis * 1  0/370 (0.00%)  1/371 (0.27%) 
Gastroenteritis viral * 1  0/370 (0.00%)  1/371 (0.27%) 
Pneumonia * 1  1/370 (0.27%)  0/371 (0.00%) 
Sepsis * 1  0/370 (0.00%)  1/371 (0.27%) 
Upper respiratory tract infection * 1  0/370 (0.00%)  1/371 (0.27%) 
Urinary tract infection * 1  1/370 (0.27%)  1/371 (0.27%) 
Injury, poisoning and procedural complications     
Fall * 1  0/370 (0.00%)  1/371 (0.27%) 
Femur fracture * 1  1/370 (0.27%)  0/371 (0.00%) 
Hip fracture * 1  2/370 (0.54%)  0/371 (0.00%) 
Humerus fracture * 1  0/370 (0.00%)  1/371 (0.27%) 
Joint dislocation * 1  1/370 (0.27%)  0/371 (0.00%) 
Lumbar vertebral fracture * 1  0/370 (0.00%)  1/371 (0.27%) 
Uterine rupture * 1  1/370 (0.27%)  0/371 (0.00%) 
Investigations     
Blood magnesium decreased * 1  1/370 (0.27%)  0/371 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  3/370 (0.81%)  1/371 (0.27%) 
Failure to thrive * 1  1/370 (0.27%)  0/371 (0.00%) 
Hypokalaemia * 1  0/370 (0.00%)  1/371 (0.27%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms * 1  1/370 (0.27%)  0/371 (0.00%) 
Muscular weakness * 1  0/370 (0.00%)  1/371 (0.27%) 
Neck pain * 1  1/370 (0.27%)  0/371 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  1/370 (0.27%)  1/371 (0.27%) 
T-cell lymphoma recurrent * 1  1/370 (0.27%)  0/371 (0.00%) 
Nervous system disorders     
Cerebral infarction * 1  1/370 (0.27%)  0/371 (0.00%) 
Cerebrovascular accident * 1  0/370 (0.00%)  1/371 (0.27%) 
Convulsion * 1  0/370 (0.00%)  2/371 (0.54%) 
Grand mal convulsion * 1  1/370 (0.27%)  0/371 (0.00%) 
Loss of consciousness * 1  0/370 (0.00%)  1/371 (0.27%) 
Syncope * 1  1/370 (0.27%)  1/371 (0.27%) 
Unresponsive to stimuli * 1  0/370 (0.00%)  1/371 (0.27%) 
Psychiatric disorders     
Abnormal behaviour * 1  0/370 (0.00%)  1/371 (0.27%) 
Agitation * 1  1/370 (0.27%)  0/371 (0.00%) 
Belligerence * 1  0/370 (0.00%)  1/371 (0.27%) 
Confusional state * 1  0/370 (0.00%)  1/371 (0.27%) 
Delusion * 1  0/370 (0.00%)  1/371 (0.27%) 
Major depression * 1  1/370 (0.27%)  0/371 (0.00%) 
Panic attack * 1  0/370 (0.00%)  1/371 (0.27%) 
Psychotic disorder * 1  0/370 (0.00%)  1/371 (0.27%) 
Renal and urinary disorders     
Bladder irritation * 1  0/370 (0.00%)  1/371 (0.27%) 
Calculus ureteric * 1  0/370 (0.00%)  1/371 (0.27%) 
Obstructive uropathy * 1  1/370 (0.27%)  0/371 (0.00%) 
Renal failure * 1  1/370 (0.27%)  0/371 (0.00%) 
Renal failure acute * 1  2/370 (0.54%)  1/371 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/370 (0.27%)  0/371 (0.00%) 
Pleural effusion * 1  0/370 (0.00%)  1/371 (0.27%) 
Pneumonia aspiration * 1  0/370 (0.00%)  1/371 (0.27%) 
Pulmonary embolism * 1  1/370 (0.27%)  0/371 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  2/370 (0.54%)  0/371 (0.00%) 
Hypertension * 1  0/370 (0.00%)  1/371 (0.27%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Dimebon Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   107/370 (28.92%)   110/371 (29.65%) 
Gastrointestinal disorders     
Constipation * 1  2/370 (0.54%)  9/371 (2.43%) 
Diarrhoea * 1  13/370 (3.51%)  9/371 (2.43%) 
Nausea * 1  8/370 (2.16%)  9/371 (2.43%) 
General disorders     
Fatigue * 1  19/370 (5.14%)  9/371 (2.43%) 
Oedema peripheral * 1  11/370 (2.97%)  9/371 (2.43%) 
Infections and infestations     
Urinary tract infection * 1  26/370 (7.03%)  27/371 (7.28%) 
Injury, poisoning and procedural complications     
Fall * 1  15/370 (4.05%)  18/371 (4.85%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  5/370 (1.35%)  10/371 (2.70%) 
Nervous system disorders     
Dizziness * 1  9/370 (2.43%)  9/371 (2.43%) 
Headache * 1  14/370 (3.78%)  10/371 (2.70%) 
Somnolence * 1  19/370 (5.14%)  7/371 (1.89%) 
Psychiatric disorders     
Agitation * 1  8/370 (2.16%)  5/371 (1.35%) 
Anxiety * 1  3/370 (0.81%)  9/371 (2.43%) 
Confusional state * 1  4/370 (1.08%)  9/371 (2.43%) 
Insomnia * 1  5/370 (1.35%)  9/371 (2.43%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
This safety study did not specify primary or secondary outcome measures. Relevant summaries of all safety assessments are thus provided. Urine blood abnormalities seen are deemed due to interference with dipstick test by a metabolite of dimebon.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00838110     History of Changes
Other Study ID Numbers: B1451027
First Submitted: February 5, 2009
First Posted: February 6, 2009
Results First Submitted: October 11, 2012
Results First Posted: February 8, 2013
Last Update Posted: December 6, 2018