A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

PHASE3CompletedINTERVENTIONAL
Enrollment

419

Participants

Timeline

Start Date

June 6, 2007

Primary Completion Date

February 13, 2008

Study Completion Date

February 13, 2008

Conditions
Insomnia
Interventions
DRUG

Esmirtazapine

Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name corn starch), magnesium stearate, and lactose monohydrate.

DRUG

Placebo

The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY