Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

December 21, 2012 updated by: Pfizer

A 52-Week, Two-Period, Multicenter, Randomized, Double-Blind, Donepezil-Referenced, Placebo-Controlled, Efficacy And Safety Study Of 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.

Study Type

Interventional

Enrollment (Actual)

526

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad de Buenos Aires, Argentina, 1022
        • Pfizer Investigational Site
      • Ciudad de Buenos Aires, Argentina, C1425BWO
        • Pfizer Investigational Site
    • Buenos Aires
      • C.a.b.a., Buenos Aires, Argentina, C1126AAB
        • Pfizer Investigational Site
      • Caba, Buenos Aires, Argentina, 1022
        • Pfizer Investigational Site
  • Chile
      • Santiago, Chile, 7530193
        • Pfizer Investigational Site
      • Santiago, Chile, 7630000
        • Pfizer Investigational Site
      • Santiago, Chile, 8330838
        • Pfizer Investigational Site
      • Santiago, Chile, 7500922
        • Pfizer Investigational Site
      • Vina del Mar, Chile, 2520997
        • Pfizer Investigational Site
  • Colombia
      • Valle del Cauca, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
    • Risaralda
      • Pereira, Risaralda, Colombia
        • Pfizer Investigational Site
    • Santander
      • Bucamaranga, Santander, Colombia
        • Pfizer Investigational Site
    • Valle
      • Cali, Valle, Colombia
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
    • Hong Kong SAR, China
      • Shatin, N.T., Hong Kong SAR, China, Hong Kong
        • Pfizer Investigational Site
  • Japan
      • Chiba, Japan
        • Pfizer Investigational Site
      • Fukuoka, Japan
        • Pfizer Investigational Site
      • Hiroshima, Japan
        • Pfizer Investigational Site
      • Kanagawa, Japan
        • Pfizer Investigational Site
      • Kumamoto, Japan
        • Pfizer Investigational Site
      • Kyoto, Japan
        • Pfizer Investigational Site
      • Nagano, Japan
        • Pfizer Investigational Site
      • Nagasaki, Japan
        • Pfizer Investigational Site
      • Shizuoka, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Hachioji, Tokyo, Japan
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Pfizer Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20127
        • Pfizer Investigational Site
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25000
        • Pfizer Investigational Site
  • New Zealand
      • Auckland, New Zealand, 0622
        • Pfizer Investigational Site
      • Hamilton, New Zealand, 3240
        • Pfizer Investigational Site
  • Poland
      • Krakow, Poland, 31-531
        • Pfizer Investigational Site
      • Poznan, Poland, 61-289
        • Pfizer Investigational Site
      • Wroclaw, Poland, 50-088
        • Pfizer Investigational Site
  • Romania
      • Bucuresti, Romania, 010825
        • Pfizer Investigational Site
      • Bucuresti, Romania, 041914
        • Pfizer Investigational Site
      • Bucuresti, Romania, 050098
        • Pfizer Investigational Site
      • Bucuresti, Romania, 011241
        • Pfizer Investigational Site
    • Dolj
      • Craiova, Dolj, Romania, 200317
        • Pfizer Investigational Site
    • Timis
      • Timisoara, Timis, Romania, 300736
        • Pfizer Investigational Site
  • Russian Federation
      • Kazan, Russian Federation, 420101
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115522
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 123182
        • Pfizer Investigational Site
      • Novosibirsk, Russian Federation, 630054
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 197022
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 190005
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 192019
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 194044
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 198103
        • Pfizer Investigational Site
      • Smolensk, Russian Federation, 214018
        • Pfizer Investigational Site
      • Yaroslavl, Russian Federation, 150030
        • Pfizer Investigational Site
    • Gatchina district, Leningrad region
      • Nikolskoe village, Gatchina district, Leningrad region, Russian Federation, 188357
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7530
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Pfizer Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Pfizer Investigational Site
      • Pretoria, Gauteng, South Africa, 0041
        • Pfizer Investigational Site
    • Western Cape
      • Bellville, Western Cape, South Africa, 7530
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85050
        • Pfizer Investigational Site
    • California
      • Costa Mesa, California, United States, 92626
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Garden Grove, California, United States, 92845
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Oxnard, California, United States, 93030
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80239
        • Pfizer Investigational Site
    • Florida
      • Brooksville, Florida, United States, 34601
        • Pfizer Investigational Site
      • Hallandale Beach, Florida, United States, 33009
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33180
        • Pfizer Investigational Site
      • Naples, Florida, United States, 34102
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33317
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33709
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33702
        • Pfizer Investigational Site
      • Sunrise, Florida, United States, 33351
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
      • aTLANTIS, Florida, United States, 33462
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Pfizer Investigational Site
      • Park Ridge, Illinois, United States, 60068
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63104
        • Pfizer Investigational Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Pfizer Investigational Site
      • Staten Island, New York, United States, 10312
        • Pfizer Investigational Site
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73116
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Pfizer Investigational Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Pfizer Investigational Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Pfizer Investigational Site
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
  • Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
  • Rosen Modified Hachinski Ischemic score < or equal to 4 at screening.

Exclusion Criteria:

  • Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
  • Current major depressive disorder or other current major psychiatric disorder.
  • History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
  • Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: Placebo
Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.
Experimental: 2
SAM-531 1.5 mg
Drug: SAM-531 1.5 mg
Capsules SAM-531 1.5 mg, once a day during 52 weeks.
Experimental: 3
SAM-531 3.0 mg
Drug: SAM-531 3.0 mg
Capsules SAM-531 3.0 mg, once a day during 52 weeks.
Experimental: 4
SAM-531 5.0 mg
Drug: SAM-531 5.0 mg
Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.
Active Comparator: 5
Donepezil
Drug: Donepezil
Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
Time Frame: Baseline, Week 24
14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24
Time Frame: Baseline, Week 24
Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant's actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of "Not Applicable" was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.
Baseline, Week 24
Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24
Time Frame: Baseline, Week 24
Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances
Baseline, Week 24
Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24
Time Frame: Baseline, Week 24
Caregiver and participant interview-based tool to rate the overall impression of participant's clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.
Baseline, Week 24
Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24
Time Frame: Baseline, Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.
Baseline, Week 24
Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24
Time Frame: Baseline, Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24
Time Frame: Baseline, Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24
Time Frame: Baseline, Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24
Time Frame: Baseline, Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24
Time Frame: Baseline, Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24
Time Frame: Baseline, Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM Strategy at Week 24
Time Frame: Baseline, Week 24
CANTAB-SWM assessed participant's ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24
Time Frame: Baseline, Week 24
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB PRM-Percentage Correct at Week 24
Time Frame: Baseline, Week 24
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24
Time Frame: Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24
Time Frame: Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24
Time Frame: Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Simple Movement Time at Week 24
Time Frame: Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24
Time Frame: Baseline, Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Percentage of Participants Who Were Responders at Week 24
Time Frame: Week 24
Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 7, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (Estimate)

May 8, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

December 21, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3193A1-2005
  • B1961007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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