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To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg PD 0200390 | Experimental |
| |
| 30 mg PD 0200390 | Experimental |
| |
| 45 mg PD 0200390 | Experimental |
| |
| 60 mg PD 0200390 | Experimental |
| |
| Placebo PD 0200390 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0200390 | Drug | Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia. | Weekly |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia. | Weekly | |
| To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35213 | United States | ||
| Pfizer Investigational Site |
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| PD 0200390 | Drug | Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days |
|
| PD 0200390 | Drug | Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days |
|
| PD 0200390 | Drug | Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days |
|
| Placebo | Drug | Matched oral placebo for weeks 2-7. |
|
| Weekly |
| To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia. | Weekly |
| To characterize the dose response relationship of PD 0200390 on subjective assessments of latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO) and total sleep time (sTST) in subjects with primary insomnia. | Weekly |
| To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia. | Weekly |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85059 | United States |
| Pfizer Investigational Site | Scottsdale | Arizona | 85254 | United States |
| Pfizer Investigational Site | Tucson | Arizona | 85712 | United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pfizer Investigational Site | Encino | California | 91316 | United States |
| Pfizer Investigational Site | Garden Grove | California | 92845 | United States |
| Pfizer Investigational Site | Los Alamitos | California | 90720 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92660 | United States |
| Pfizer Investigational Site | Redlands | California | 92374 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | San Diego | California | 92120 | United States |
| Pfizer Investigational Site | Sherman Oaks | California | 91403 | United States |
| Pfizer Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| Pfizer Investigational Site | Brooksville | Florida | 34613 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Hallandale | Florida | 330009 | United States |
| Pfizer Investigational Site | Hallandale | Florida | 33009 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Jupiter | Florida | 33458 | United States |
| Pfizer Investigational Site | Maitland | Florida | 32751 | United States |
| Pfizer Investigational Site | Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| Pfizer Investigational Site | Spring Hill | Florida | 34609 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33609-4052 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33609 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33613 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33614 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Gainsville | Georgia | 30501 | United States |
| Pfizer Investigational Site | Macon | Georgia | 31201 | United States |
| Pfizer Investigational Site | Arlington Heights | Illinois | 60004 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60607 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60622 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47714 | United States |
| Pfizer Investigational Site | Newburgh | Indiana | 47630 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40504 | United States |
| Pfizer Investigational Site | Mount Sterling | Kentucky | 40353 | United States |
| Pfizer Investigational Site | Mount Sterlingg | Kentucky | 40353 | United States |
| Pfizer Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48104 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49009 | United States |
| Pfizer Investigational Site | Saint Clair Shores | Michigan | 48081 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| Pfizer Investigational Site | New York | New York | 10019 | United States |
| Pfizer Investigational Site | Staten Island | New York | 10312 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28207 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27710 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44122 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43213 | United States |
| Pfizer Investigational Site | Dayton | Ohio | 45408 | United States |
| Pfizer Investigational Site | Kettering | Ohio | 45429 | United States |
| Pfizer Investigational Site | Toledo | Ohio | 43623 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | East Providence | Rhode Island | 02914 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29407 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38117 | United States |
| Pfizer Investigational Site | Austin | Texas | 78754 | United States |
| Pfizer Investigational Site | Austin | Texas | 78756 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Houston | Texas | 77024 | United States |
| Pfizer Investigational Site | Houston | Texas | 77063 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Newport News | Virginia | 23606 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98104 | United States |
| Pfizer Investigational Site | Calgary | Alberta | T2X 2A8 | Canada |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 2H4 | Canada |
| Pfizer Investigational Site | Sydney | Nova Scotia | B1P 1C6 | Canada |
| Pfizer Investigational Site | Brampton | Ontario | L6Y 2R2 | Canada |
| Pfizer Investigational Site | Etobicoke | Ontario | M9W 6V1 | Canada |
| Pfizer Investigational Site | Kitchener | Ontario | N2G 1G1 | Canada |
| Pfizer Investigational Site | Mississauga | Ontario | L5B 4M4 | Canada |
| Pfizer Investigational Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| Pfizer Investigational Site | Parry Sound | Ontario | P2A 3A4 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M3K 2A7 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M4P 1P2 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5T 3A9 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M6J 3S3 | Canada |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C547571 | (1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid |
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