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Trial record 29 of 1893 for:    Diseases | ( Map: Puerto Rico )

An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00939783
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : July 15, 2009
Results First Posted : November 14, 2012
Last Update Posted : November 14, 2012
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Intervention Drug: Dimebon
Enrollment 649
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dimebon
Hide Arm/Group Description Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
Period Title: Overall Study
Started 649
Treated 648
Completed 0
Not Completed 649
Reason Not Completed
Death             6
Adverse Event             39
Study Terminated by Sponsor             498
Withdrawal by Subject             78
Other             16
Lost to Follow-up             8
Protocol Violation             3
Enrolled but not treated             1
Arm/Group Title Dimebon
Hide Arm/Group Description Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
Overall Number of Baseline Participants 648
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 648 participants
50 to 59 years 32
60 to 69 years 100
70 to 79 years 269
80 to 85 years 187
Greater than 85 years 60
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 648 participants
Female
342
  52.8%
Male
306
  47.2%
1.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs)
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 65 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all the participants who received at least one dose of study medication, including partial doses.
Arm/Group Title Dimebon
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
Overall Number of Participants Analyzed 648
Measure Type: Number
Unit of Measure: Percentage of participants
73.1
2.Secondary Outcome
Title Percentage of Participants With Abnormal Clinically Significant Vital Signs
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 for systolic BP; absolute diastolic BP <50 mmHg with maximum increase or decrease of >=20 mmHg from baseline and absolute heart rate values <40 beats per minute (bpm), >120 bpm for supine or sitting measurement, >140 bpm for standing measurement.
Time Frame Baseline up to Week 65 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.
Arm/Group Title Dimebon
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
Overall Number of Participants Analyzed 646
Measure Type: Number
Unit of Measure: Percentage of participants
Systolic BP (<90 mmHg) (n=646) 1.1
Increase in systolic BP (>=30 mmHg) (n=642) 11.5
Decrease in systolic BP (>=30 mmHg) (n=642) 12.0
Diastolic BP (<50 mmHg) (n=646) 2.0
Increase in diastolic BP (>=20 mmHg) (n=642) 8.1
Decrease in diastolic BP (>=20 mmHg) (n=642) 9.7
Heart rate (<40 bpm) (n=646) 0.0
Heart rate (>120/>140 bpm) (n=646) 0.0
3.Secondary Outcome
Title Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Hide Description For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if observed value was more than or less than X times upper limit of normal (ULN) or lower limit of normal (LLN); X=specified in categories of each parameter in measured values section. For urinalysis abnormality was reported if result was >=1 in qualitative test of all parameters except red and white blood cells which were reported if result was >=6, indicating levels in urine were abnormal. Urine pH abnormality reported if >8 and urine specific gravity abnormality if <1.003 or >1.030.
Time Frame Baseline up to Week 65 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular laboratory parameter.
Arm/Group Title Dimebon
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
Overall Number of Participants Analyzed 646
Measure Type: Number
Unit of Measure: Percentage of participants
Hemoglobin (<0.8*LLN) (n=646) 0.3
Red blood cell count (< 0.8*LLN) (n=646) 0.5
Mean corpuscular volume (<0.9*LLN) (n=646) 0.8
Mean corpuscular volume (>1.1*ULN) (n=646) 0.2
Platelets (>1.75*ULN) (n=646) 0.2
White blood cell count (<0.6*LLN) (n=646) 0.2
White blood cell count (>1.5*ULN) (n=646) 0.2
Lymphocytes (<0.8*LLN) (n=646) 1.4
Lymphocytes (>1.2*ULN) (n=646) 2.6
Total neutrophils (<0.8*LLN) (n=646) 0.6
Total neutrophils (>1.2*ULN) (n=646) 4.3
Eosinophils (>1.2*ULN) (n=646) 1.4
Monocytes (>1.2*ULN) (n=646) 1.5
Total bilirubin(>1.5*ULN) (n=646) 0.3
Aspartate aminotransferase (>3.0*ULN) (n=645) 0.5
Alanine aminotransferase (>3.0*ULN) (n=645) 0.9
Alkaline phosphatase (>3.0*ULN) (n=646) 0.2
Albumin (>1.2*ULN) (n=646) 0.2
Blood urea nitrogen (>1.3*ULN) (n=646) 1.4
Creatinine (>1.3*ULN) (n=646) 1.4
Sodium (<0.95*LLN) (n=646) 0.3
Sodium (>1.05*ULN) (n=646) 0.9
Potassium (<0.9*LLN) (n=645) 0.6
Potassium (>1.1*ULN) (n=645) 0.5
Calcium (>1.1*ULN) (n=646) 0.3
Magnesium (<0.9*LLN) (n=646) 0.5
Magnesium (>1.1*ULN) (n=646) 22.0
Phosphate (<0.8*LLN) (n=646) 0.2
Phosphate (>1.2*ULN) (n=646) 0.2
Bicarbonate (<0.9*LLN) (n=646) 0.8
Bicarbonate (>1.1*ULN) (n=646) 0.2
Glucose (>1.5*ULN) (n=646) 17.6
Creatine kinase (>2.0*ULN) (n=646) 2.5
Urine specific gravity (>1.030) (n=643) 3.4
Urine pH (>8) (n=643) 0.3
Urine glucose (>=1) (n=643) 5.3
Urine ketones (>=1) (n=643) 2.2
Urine protein (>=1) (n=643) 3.3
Urine blood (>=1) (n=643) 52.1
Urine leukocyte esterase (>=1) (n=643) 29.4
Urine RBC (>=6) (n=518) 18.1
Urine WBC (>=6) (n=562) 34.3
4.Secondary Outcome
Title Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
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 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 >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).
Time Frame Baseline up to Week 65 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.
Arm/Group Title Dimebon
Hide Arm/Group Description:
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
Overall Number of Participants Analyzed 646
Measure Type: Number
Unit of Measure: Percentage of participants
PR int (>=300 msec) (n=608) 0.3
Increase in PR int (>=25/50%) (n=605) 0.3
Increase in QRS int (>=25/50%) (n=646) 1.4
QTcF int (>450 to <=480 msec) (n=646) 18.3
QTcF int (>480 to <=500 msec) (n=646) 1.9
QTcF int (>500 msec) (n=646) 0.3
Increase in QTcF int (>30 to <=60 msec) (n=646) 8.0
Increase in QTcF int (>60 msec) (n=646) 0.3
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
Hide Arm/Group Description Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
All-Cause Mortality
Dimebon
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dimebon
Affected / at Risk (%)
Total   76/648 (11.73%) 
Cardiac disorders   
Angina pectoris * 1  1/648 (0.15%) 
Atrial flutter * 1  1/648 (0.15%) 
Atrioventricular block second degree * 1  1/648 (0.15%) 
Bradycardia * 1  2/648 (0.31%) 
Cardiac arrest * 1  2/648 (0.31%) 
Myocardial infarction * 1  2/648 (0.31%) 
Sick sinus syndrome * 1  1/648 (0.15%) 
Sinus arrhythmia * 1  1/648 (0.15%) 
Supraventricular extrasystoles * 1  1/648 (0.15%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/648 (0.15%) 
Diarrhoea * 1  1/648 (0.15%) 
Inguinal hernia * 1  1/648 (0.15%) 
Intestinal perforation * 1  1/648 (0.15%) 
Pancreatic mass * 1  1/648 (0.15%) 
Pancreatitis * 1  1/648 (0.15%) 
Upper gastrointestinal haemorrhage * 1  1/648 (0.15%) 
Volvulus * 1  1/648 (0.15%) 
General disorders   
Chest discomfort * 1  2/648 (0.31%) 
Chest pain * 1  6/648 (0.93%) 
Pyrexia * 1  1/648 (0.15%) 
Hepatobiliary disorders   
Bile duct stone * 1  1/648 (0.15%) 
Cholangitis acute * 1  1/648 (0.15%) 
Cholecystitis * 1  1/648 (0.15%) 
Cholelithiasis * 1  1/648 (0.15%) 
Jaundice * 1  1/648 (0.15%) 
Immune system disorders   
Hypersensitivity * 1  1/648 (0.15%) 
Infections and infestations   
Appendicitis perforated * 1  1/648 (0.15%) 
Bronchitis * 1  2/648 (0.31%) 
Cellulitis * 1  2/648 (0.31%) 
Clostridial infection * 1  1/648 (0.15%) 
Clostridium difficile colitis * 1  1/648 (0.15%) 
Device related infection * 1  1/648 (0.15%) 
Herpes zoster * 1  1/648 (0.15%) 
Pneumonia * 1  3/648 (0.46%) 
Sepsis * 1  3/648 (0.46%) 
Urinary tract infection * 1  6/648 (0.93%) 
Injury, poisoning and procedural complications   
Facial bones fractures * 1  1/648 (0.15%) 
Fall * 1  3/648 (0.46%) 
Femur fracture * 1  3/648 (0.46%) 
Fracture * 1  1/648 (0.15%) 
Hip fracture * 1  6/648 (0.93%) 
Joint dislocation * 1  1/648 (0.15%) 
Spinal compression fracture * 1  1/648 (0.15%) 
Subdural haematoma * 1  1/648 (0.15%) 
Upper limb fracture * 1  1/648 (0.15%) 
Uterine rupture * 1  1/648 (0.15%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/648 (0.15%) 
Failure to thrive * 1  1/648 (0.15%) 
Hypokalaemia * 1  2/648 (0.31%) 
Hypomagnesaemia * 1  1/648 (0.15%) 
Musculoskeletal and connective tissue disorders   
Bursitis * 1  1/648 (0.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer * 1  1/648 (0.15%) 
Tongue neoplasm malignant stage unspecified * 1  1/648 (0.15%) 
Nervous system disorders   
Cerebral haemorrhage * 1  1/648 (0.15%) 
Cerebrovascular accident * 1  2/648 (0.31%) 
Dementia Alzheimer's type * 1  1/648 (0.15%) 
Grand mal convulsion * 1  1/648 (0.15%) 
Mental impairment * 1  2/648 (0.31%) 
Presyncope * 1  1/648 (0.15%) 
Syncope * 1  2/648 (0.31%) 
Transient ischaemic attack * 1  2/648 (0.31%) 
Psychiatric disorders   
Acute psychosis * 1  1/648 (0.15%) 
Agitation * 1  1/648 (0.15%) 
Delirium * 1  3/648 (0.46%) 
Mental status changes * 1  3/648 (0.46%) 
Psychotic disorder * 1  1/648 (0.15%) 
Renal and urinary disorders   
Nephrolithiasis * 1  1/648 (0.15%) 
Renal failure acute * 1  1/648 (0.15%) 
Urinary retention * 1  2/648 (0.31%) 
Reproductive system and breast disorders   
Calculus prostatic * 1  1/648 (0.15%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease * 1  2/648 (0.31%) 
Dyspnoea * 1  1/648 (0.15%) 
Pneumonia aspiration * 1  1/648 (0.15%) 
Pulmonary embolism * 1  1/648 (0.15%) 
Vascular disorders   
Deep vein thrombosis * 1  2/648 (0.31%) 
Haemodynamic instability * 1  1/648 (0.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Dimebon
Affected / at Risk (%)
Total   313/648 (48.30%) 
Gastrointestinal disorders   
Constipation * 1  17/648 (2.62%) 
Diarrhoea * 1  28/648 (4.32%) 
Nausea * 1  15/648 (2.31%) 
General disorders   
Fatigue * 1  28/648 (4.32%) 
Oedema peripheral * 1  22/648 (3.40%) 
Infections and infestations   
Bronchitis * 1  13/648 (2.01%) 
Upper respiratory tract infection * 1  14/648 (2.16%) 
Urinary tract infection * 1  73/648 (11.27%) 
Injury, poisoning and procedural complications   
Contusion * 1  22/648 (3.40%) 
Fall * 1  59/648 (9.10%) 
Investigations   
Weight increased * 1  13/648 (2.01%) 
Musculoskeletal and connective tissue disorders   
Anthralgia * 1  16/648 (2.47%) 
Back pain * 1  15/648 (2.31%) 
Nervous system disorders   
Dizziness * 1  20/648 (3.09%) 
Headache * 1  25/648 (3.86%) 
Memory impairment * 1  15/648 (2.31%) 
Somnolence * 1  43/648 (6.64%) 
Psychiatric disorders   
Agitation * 1  20/648 (3.09%) 
Anxiety * 1  19/648 (2.93%) 
Confusional state * 1  23/648 (3.55%) 
Depression * 1  18/648 (2.78%) 
Insomnia * 1  15/648 (2.31%) 
Vascular disorders   
Hypertension * 1  18/648 (2.78%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: NCT00939783     History of Changes
Other Study ID Numbers: B1451029
First Submitted: July 13, 2009
First Posted: July 15, 2009
Results First Submitted: October 11, 2012
Results First Posted: November 14, 2012
Last Update Posted: November 14, 2012