Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

PHASE3CompletedINTERVENTIONAL
Enrollment

526

Participants

Timeline

Start Date

December 7, 2006

Primary Completion Date

August 11, 2008

Study Completion Date

August 11, 2008

Conditions
Insomnia
Interventions
DRUG

Esmirtazapine

Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, 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. Tablets were administered orally once daily about 30 minutes prior to bedtime.

DRUG

Placebo

Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00482612 - Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706) | Biotech Hunter | Biotech Hunter