CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 709 enrolled
Drug / intervention
almorexant +3 moredrug
Likely dose
almorexant 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00608985
NCT00608985Phase 3Completed
CompareCT.gov

Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia

Midnight Pharma, LLC·interventional·Posted Feb 6, 2008·Updated Mar 14, 2016

In Brief

A Phase 3 clinical trial evaluating almorexant, Placebo, and 1 other intervention for Primary Insomnia. Completed, enrolled 709 participants across 91 sites in 20 countries.

Detailed Summary

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Insomnia
CountriesAustralia, Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2008
Enrollment StartMar 1, 2008
Primary CompletionSep 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.4 years ago

Interventions

almorexantdrug

2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexantdrug

1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

Placebodrug

2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

zolpidemdrug

2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated