NCT00548340

VEC-162 Study in Adult Patients With Primary Insomnia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 (20 mg/Day and 50 mg/Day) in the Treatment of Primary Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	VEC-162 20 mg	20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
DRUG	Placebo	Placebo capsules, PO daily for five weeks
DRUG	VEC-162 50 mg	50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-02-01
• Completion: 2008-06-01
• First posted: 2007-10-23
• Last updated: 2014-10-15
• Results posted: 2014-10-15

Locations

35 sites across 1 country: United States