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

NCT ID: NCT00939783

Last Updated: 2012-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

649 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dimebon 20 mg TID

10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Tablet for oral administration

Interventions

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Dimebon

Tablet for oral administration

Intervention Type DRUG

Other Intervention Names

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PF-01913539

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medivation, Inc.

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Mobile, Alabama, United States

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Northport, Alabama, United States

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Little Rock, Arkansas, United States

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Oceanside, California, United States

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San Diego, California, United States

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Santa Rosa, California, United States

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Pueblo, Colorado, United States

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Hockessin, Delaware, United States

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Bradenton, Florida, United States

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Brooksville, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Fort Myers, Florida, United States

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Fort Walton Beach, Florida, United States

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Maitland, Florida, United States

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Melbourne, Florida, United States

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Naples, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Plant City, Florida, United States

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Port Charlotte, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Burr Ridge, Illinois, United States

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Elk Grove Village, Illinois, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Fort Wayne, Indiana, United States

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Greenfield, Indiana, United States

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Prairie Village, Kansas, United States

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Wichita, Kansas, United States

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Lake Charles, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Hyannis, Massachusetts, United States

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Flowood, Mississippi, United States

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Olive Branch, Mississippi, United States

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Springfield, Missouri, United States

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Great Falls, Montana, United States

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Eatontown, New Jersey, United States

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Oakhurst, New Jersey, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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Amherst, New York, United States

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Buffalo, New York, United States

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Buffalo, New York, United States

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Orchard Park, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Bridgeville, Pennsylvania, United States

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Grove City, Pennsylvania, United States

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Indiana, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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Upper Saint Clair, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Murrells Inlet, South Carolina, United States

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North Charleston, South Carolina, United States

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Orangeburg, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Franklin, Tennessee, United States

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Knoxville, Tennessee, United States

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Carrollton, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Grand Prairie, Texas, United States

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Lake Jackson, Texas, United States

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Williamsburg, Virginia, United States

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Kirkland, Washington, United States

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Spokane, Washington, United States

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Charleston, West Virginia, United States

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La Crosse, Wisconsin, United States

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Calgary, Alberta, Canada

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Medicine Hat, Alberta, Canada

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Victoria, British Columbia, Canada

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Saint John, New Brunswick, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Kentville, Nova Scotia, Canada

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Pictou, Nova Scotia, Canada

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Burlington, Ontario, Canada

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London, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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L'Ancienne-Lorette, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Jean-sur-Richelieu, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Cayey, , Puerto Rico

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Cidra, , Puerto Rico

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San Juan, , Puerto Rico

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San Juan, , Puerto Rico

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Countries

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United States Canada Puerto Rico

Related Links

Other Identifiers

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B1451029

Identifier Type: -

Identifier Source: org_study_id