Clinical Trials/NCT00266357

NCT00266357TerminatedPhase 2

MK0928 Phase II Sleep Laboratory Study - Primary Insomnia

H. Lundbeck A/S0 sites50 target enrollmentStarted: November 1, 2005Last updated: January 14, 2015

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Terminated
Sponsor: H. Lundbeck A/S
Enrollment: 50
Primary Endpoint: Mean of total sleep time over 2 nights.

Study Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 20 Years to 64 Years (Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Patients with a diagnosis of primary insomnia

Exclusion Criteria

•Patients with an active psychiatric disorder other than primary insomnia

Outcomes

Primary Outcomes

Mean of total sleep time over 2 nights.

Secondary Outcomes

Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.

Investigators

Sponsor

H. Lundbeck A/S

Sponsor Class

Industry

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JPRN-UMIN000014154Department of Neurology, School of Medicine, Keio University80