A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
NCT ID: NCT00569972
Last Updated: 2012-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
682 participants
INTERVENTIONAL
2007-10-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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15 mg PD 0200390
PD 0200390
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
30 mg PD 0200390
PD 0200390
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
45 mg PD 0200390
PD 0200390
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
60 mg PD 0200390
PD 0200390
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Placebo PD 0200390
Placebo
Matched oral placebo for weeks 2-7.
Interventions
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PD 0200390
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
PD 0200390
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
PD 0200390
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
PD 0200390
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Placebo
Matched oral placebo for weeks 2-7.
Eligibility Criteria
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Inclusion Criteria
* 18 to 64 years
* For the last 3 months-regularly awake unrefreshed and unrestored
* Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
Exclusion Criteria
* History or presence of any breathing related sleep disorder;
* History or presence of any medical or neurological condition that could interfere with sleep
* Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
18 Years
64 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Encino, California, United States
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Garden Grove, California, United States
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Los Alamitos, California, United States
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Newport Beach, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Sherman Oaks, California, United States
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Colorado Springs, Colorado, United States
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Brooksville, Florida, United States
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DeLand, Florida, United States
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Hallandale, Florida, United States
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Hallandale, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Spring Hill, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Gainsville, Georgia, United States
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Macon, Georgia, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Newburgh, Indiana, United States
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Lexington, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Mount Sterlingg, Kentucky, United States
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Chevy Chase, Maryland, United States
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Ann Arbor, Michigan, United States
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Kalamazoo, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Staten Island, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Kettering, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Newport News, Virginia, United States
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Seattle, Washington, United States
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Calgary, Alberta, Canada
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Kelowna, British Columbia, Canada
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Sydney, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Etobicoke, Ontario, Canada
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Kitchener, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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Parry Sound, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Countries
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Other Identifiers
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A4251037
Identifier Type: -
Identifier Source: org_study_id