VEC-162 Study in Adult Patients With Primary Insomnia

This study has been completed.

Sponsor:

Information provided by:

Vanda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00548340

First received: October 19, 2007

Last updated: June 9, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 19, 2007
Last Updated Date	June 9, 2011
Start Date ^ICMJE	November 2007
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 9, 2008)	Average latency to persistent sleep (LPS) [ Time Frame: baseline and short-term in-treatment time points ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: October 19, 2007)	Average latency to persistent sleep (LPS)
Change History	Complete list of historical versions of study NCT00548340 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 9, 2008)	Average Wake After Sleep Onset (WASO), sleep duration, subjective measures of sleep, and safety and tolerability [ Time Frame: all in-treatment time points across five week period ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 19, 2007)	Average Wake After Sleep Onset (WASO), sleep duration, subjective measures of sleep, and safety and tolerability
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	VEC-162 Study in Adult Patients With Primary Insomnia
Official Title ^ICMJE	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
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Primary Insomnia
Intervention ^ICMJE	Drug: VEC-162 20 mg or 50 mg VEC-162 capsules, PO daily for five weeks Drug: Placebo Placebo capsules, PO daily for five weeks
Study Arm (s)	Experimental: 1 VEC-162 20 mg Intervention: Drug: VEC-162 Experimental: 2 VEC-162 50 mg Intervention: Drug: VEC-162 Placebo Comparator: 3 Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	322
Completion Date	June 2008
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males and females with a diagnosis of primary insomnia as defined in DSM-IV. Habitual bedtime between 9:00 pm and 1:00 am. No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea. Patients must sign a written consent form. Exclusion Criteria: History of drug or alcohol abuse as defined in DSM-IV. History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium. History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia. Recent history of shift work or jet lag.
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00548340
Other Study ID Numbers ^ICMJE	VP-VEC-162-3104
Has Data Monitoring Committee	Not Provided
Responsible Party	Paolo Baroldi, MD, PhD, Vanda Pharmaceuticals
Study Sponsor ^ICMJE	Vanda Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vanda Pharmaceuticals
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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