An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease
The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 65 (end of treatment) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||September 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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
This study was terminated on May 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well -tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939783
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|