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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Dimebon||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||649 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon (PF 01913539) In Patients With Alzheimer's Disease|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Experimental: Dimebon 20 mg TID
10 mg TID for Week 1, followed by 20 mg TID for remainder of study
Tablet for oral administration
Other Name: PF-01913539
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 65 (end of treatment) ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
- Percentage of Participants With Abnormal Clinically Significant Vital Signs [ Time Frame: Baseline up to Week 65 (end of treatment) ]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.
- Percentage of Participants With Abnormal Clinically Significant Laboratory Values [ Time Frame: Baseline up to Week 65 (end of treatment) ]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.
- Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings [ Time Frame: Baseline up to Week 65 (end of treatment) ]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).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939783
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|