At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 82 enrolled
Drug / intervention
suvorexant +1 moredrug
Likely dose
suvorexant 20mgfrom 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.
A Multi-center, Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Suvorexant Versus Placebo on Sleep Pressure and Circadian Rhythm in Hypertensives With Insomnia: The Super 1 Study
In Brief
A Phase 4 clinical trial evaluating suvorexant and Placebo for Hypertension and Insomnia. Completed, enrolled 82 participants across 3 sites.
Detailed Summary
The purpose of this study is to compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Insomnia
CountriesJapan
CollaboratorsMerck Sharp & Dohme LLC, Satt Co.,Ltd
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartJan 2017
Primary CompletionOct 2017
Study CompletionMar 2018
TodayJul 2026
First PostedJul 29, 2016
Enrollment StartJan 17, 2017
Primary CompletionOct 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.9 years ago
Interventions
suvorexantdrug
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
Placeboother
Placebo once daily before bedtime.