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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00939783
• Other study ID #: B1451029
• Status: Terminated
• Phase: Phase 3
• First received: July 13, 2009
• Last updated: October 11, 2012
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 649
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Completion of previous Phase 3 Dimebon study (B1451027).

Exclusion Criteria:

• Have any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Dimebon
Tablet for oral administration

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Burlington	Ontario
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Kentville	Nova Scotia
Canada	Pfizer Investigational Site	L'Ancienne-Lorette	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Medicine Hat	Alberta
Canada	Pfizer Investigational Site	Pictou	Nova Scotia
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Saint John	New Brunswick
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	St-Jean-sur-Richelieu	Quebec
Canada	Pfizer Investigational Site	St. Leonard	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Puerto Rico	Pfizer Investigational Site	Cayey
Puerto Rico	Pfizer Investigational Site	Cidra
Puerto Rico	Pfizer Investigational Site	San Juan
Puerto Rico	Pfizer Investigational Site	San Juan
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Altoona	Pennsylvania
United States	Pfizer Investigational Site	Amherst	New York
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Beaver	Pennsylvania
United States	Pfizer Investigational Site	Bradenton	Florida
United States	Pfizer Investigational Site	Bridgeville	Pennsylvania
United States	Pfizer Investigational Site	Brooksville	Florida
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Burr Ridge	Illinois
United States	Pfizer Investigational Site	Carrollton	Texas
United States	Pfizer Investigational Site	Charleston	West Virginia
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Eatontown	New Jersey
United States	Pfizer Investigational Site	Elk Grove Village	Illinois
United States	Pfizer Investigational Site	Elkhart	Indiana
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Flowood	Mississippi
United States	Pfizer Investigational Site	Fort Myers	Florida
United States	Pfizer Investigational Site	Fort Walton Beach	Florida
United States	Pfizer Investigational Site	Fort Wayne	Indiana
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Franklin	Tennessee
United States	Pfizer Investigational Site	Grand Prairie	Texas
United States	Pfizer Investigational Site	Great Falls	Montana
United States	Pfizer Investigational Site	Greenfield	Indiana
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Grove City	Pennsylvania
United States	Pfizer Investigational Site	Hockessin	Delaware
United States	Pfizer Investigational Site	Hyannis	Massachusetts
United States	Pfizer Investigational Site	Indiana	Pennsylvania
United States	Pfizer Investigational Site	Kirkland	Washington
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	La Crosse	Wisconsin
United States	Pfizer Investigational Site	Lake Charles	Louisiana
United States	Pfizer Investigational Site	Lake Jackson	Texas
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Maitland	Florida
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Murrells Inlet	South Carolina
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Norristown	Pennsylvania
United States	Pfizer Investigational Site	North Charleston	South Carolina
United States	Pfizer Investigational Site	Northport	Alabama
United States	Pfizer Investigational Site	Oakhurst	New Jersey
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Olive Branch	Mississippi
United States	Pfizer Investigational Site	Orangeburg	South Carolina
United States	Pfizer Investigational Site	Orchard Park	New York
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Plant City	Florida
United States	Pfizer Investigational Site	Port Charlotte	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Prairie Village	Kansas
United States	Pfizer Investigational Site	Pueblo	Colorado
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Santa Rosa	California
United States	Pfizer Investigational Site	Scotland	Pennsylvania
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Sioux Falls	South Dakota
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	St. Petersburg	Florida
United States	Pfizer Investigational Site	St. Petersburg	Florida
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Toms River	New Jersey
United States	Pfizer Investigational Site	Upper St. Clair	Pennsylvania
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Williamsburg	Virginia
United States	Pfizer Investigational Site	Winston Salem	North Carolina
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Baseline up to Week 65 (end of treatment)	Yes
Secondary	Percentage of Participants With Abnormal Clinically Significant Vital Signs	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.	Baseline up to Week 65 (end of treatment)	Yes
Secondary	Percentage of Participants With Abnormal Clinically Significant Laboratory Values	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.	Baseline up to Week 65 (end of treatment)	Yes
Secondary	Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings	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).	Baseline up to Week 65 (end of treatment)	Yes

External Links

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