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VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

NCT ID: NCT00291187

Last Updated: 2014-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-08-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Take orally 30 minutes prior to bedtime.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

20 mg VEC-162

20 mg taken orally 30 minutes prior to bedtime.

Group Type EXPERIMENTAL

20 mg VEC-162

Intervention Type DRUG

20 mg VEC-162

50 mg VEC-162

50 mg taken orally 30 minutes prior to bedtime.

Group Type EXPERIMENTAL

50 mg VEC-162

Intervention Type DRUG

50 mg VEC-162

100 mg VEC-162

100 mg taken orally 30 minutes prior to bedtime.

Group Type EXPERIMENTAL

100 mg VEC-162

Intervention Type DRUG

100 mg VEC-162

Interventions

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20 mg VEC-162

20 mg VEC-162

Intervention Type DRUG

50 mg VEC-162

50 mg VEC-162

Intervention Type DRUG

100 mg VEC-162

100 mg VEC-162

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects with no medical, psychiatric or current sleep disorders.
* Subject must sign a written consent form.

Exclusion Criteria

* Recent history of night shift work or jet lag.
* Prior experience sleeping in a sleep lab environment.
* History of sleep disorders.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanda Pharmaceuticals

Role: STUDY_DIRECTOR

Vanda Pharmaceuticals

Locations

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Vanda Investigational Site

Birmingham, Alabama, United States

Site Status

Vanda Investigational Site

Phoenix, Arizona, United States

Site Status

Vanda Investigational Site

San Diego, California, United States

Site Status

Vanda Investigational Site

San Francisco, California, United States

Site Status

Vanda Investigational Site

Santa Monica, California, United States

Site Status

Vanda Investigational Site

Miami, Florida, United States

Site Status

Vanda Investigational Site

Naples, Florida, United States

Site Status

Vanda Investigational Site

Pembroke Pines, Florida, United States

Site Status

Vanda Investigational Site

St. Petersburg, Florida, United States

Site Status

Vanda Investigational Site

Atlanta, Georgia, United States

Site Status

Vanda Investigational Site

Overland Park, Kansas, United States

Site Status

Vanda Investigational Site

Chevy Chase, Maryland, United States

Site Status

Vanda Investigational Site

New York, New York, United States

Site Status

Vanda Investigational Site

Rochester, New York, United States

Site Status

Vanda Investigational Site

Raleigh, North Carolina, United States

Site Status

Vanda Investigational Site

Cincinnati, Ohio, United States

Site Status

Vanda Investigational Site

Columbia, South Carolina, United States

Site Status

Vanda Investigational Site

Austin, Texas, United States

Site Status

Vanda Investigational Site

Plano, Texas, United States

Site Status

Countries

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United States

References

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Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4.

Reference Type DERIVED
PMID: 19054552 (View on PubMed)

Other Identifiers

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VP-VEC-162-3101

Identifier Type: -

Identifier Source: org_study_id

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