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A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

NCT00569972 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2012-07-25

No results posted yet for this study

Summary

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

Conditions

Interventions

DRUG

PD 0200390

Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days

DRUG

PD 0200390

Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days

DRUG

PD 0200390

Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days

DRUG

PD 0200390

Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days

DRUG

Placebo

Matched oral placebo for weeks 2-7.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00569972 on ClinicalTrials.gov