Expired Study
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Little Rock, Arkansas 72205


Purpose:

In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.


Criteria:

Inclusion Criteria: - Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening - Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos - PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins. Exclusion Criteria: - MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening - BMI = or > 32 kg/m2 - History or presence of breathing related disorders - PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb movement with arousal index > 10/hr.


NCT ID:

NCT00655369


Primary Contact:

Study Director
Pfizer CT.gov Call Center
Pfizer


Backup Contact:

N/A


Location Contact:

Little Rock, Arkansas 72205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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