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Completed

NCT Number: NCT02849184

To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Takahira Internal Medicine Clinic, Fukuoka, Japan

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About this study

The study consists of a 4-week run-in period and a 2-week treatment period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

[At interim registration]

Patients who meet the following criteria are eligible for the study:

  • Patients who give written consent of agreement to voluntarily participation in the clinical study
  • Age 20 years or older
  • Sex: Male or female
  • Treatment classification: Outpatient
  • Hypertensive patient who meet at least one of the following:
  • Under antihypertensive medications
  • Clinic systolic blood pressure (SBP) less than 160 mmHg
  • Patients with insomnia who meet at least one of the following:
  • Patients with any one of the following symptoms twice a week or more and at least 1 month-continuation: difficulty initiating sleep (time to sleep onset 2 hours or more longer than usual), difficulty maintaining sleep (awakening twice or more in the night), early morning awakening (awakening 2 hours or more earlier in the morning than usual), difficulty sleeping deeply (no soundly asleep feeling at the time of awakening in the morning).

b. Patients with interference with social or occupational function due to the above insomnia symptoms

[At official registration]

Patients who meet the following criteria at the end of run-in period are eligible for the study:

  • Stable unchanged antihypertensive medication for run-in period.
  • Average morning home SBP more than 135 mmHg during 5 days before the end of run-in period.

Exclusion criteria

  • Patients with serious liver disease.
  • Patients with serious respiratory disease.
  • Patients with secondary hypertension
  • Patients with sleep apnea syndrome
  • Patients with history of narcolepsy or cataplexy
  • Patients with history of organic cerebral disorders
  • Patients with history of hypersensitivity to suvorexant
  • Patients received CYP3A strongly-inhibitors including itraconazole, clarithromycin and ritonavir, saquinavir, nelfinavir, indinavir, telaprevir and voriconazole at the start of the run-in period
  • Patients with average clinic SBP of 160 mmHg or more at the start of the run-in period
  • Patients received suvorexant and other hypnotic at the start of the run-in period on a regular basis
  • Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
  • Patients who are considered not to be eligible for this study by their investigator or sub-investigator

Treatment and study plan

Suvorexant

Drug

Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.

Other names: Belsomra

Placebo

Other

Placebo once daily before bedtime.

Primary outcomes

  1. Change in Sleep Systolic Blood Pressure

    Time frame: 2 weeks

    To compare the efficacy of suvorexant versus placebo on sleep systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM).

    Change: sleep SBP value at 2 weeks minus value at baseline

Secondary outcomes

  1. Change in Morning Systolic Blood Pressure Variability

    Time frame: 2 weeks

    To compare the efficacy of suvorexant versus placebo on morning SBP variability by ABPM Variability: SD Change: value at 2 weeks minus value at baseline

  2. Changes in the Total Sleep Time

    Time frame: 2 weeks

    Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0

  3. Changes in the Time to Sleep Onset

    Time frame: 2 weeks

    Time to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0

  4. Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction

    Time frame: 2 weeks

    nighttime BPs are measured by ambulatory blood pressure monitoring. Sleep quality is measured by self-reported sleep diary (satisfaction level of sleep) at 2 weeks.

    Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline).

  5. Change in Urinary Albumin-to-creatinine Ratio (UACR)

    Time frame: 2 weeks

    Percentage change in UACR from baseline to 2 weeks

  6. Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction

    Time frame: 2 weeks

    nighttime BPs are measured by ambulatory blood pressure monitoring. Sleep quality is measured by self-reported sleep diary (satisfaction level of sleep) at 2weeks.

    Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline).

  7. Change in NT-proBNP

    Time frame: 2 weeks

    Percentage change in NT-proBNP from baseline to 2 weeks

Sponsors and collaborators

Lead sponsor

Jichi Medical University

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Satt Co.,Ltd

Registry information

Official study title

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

Acronym: Super1

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 29, 2016
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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