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To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia (Super1)

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ClinicalTrials.gov Identifier: NCT02849184
Recruitment Status : Completed
First Posted : July 29, 2016
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Satt Co.,Ltd
Information provided by (Responsible Party):
Kazuomi Kario, Jichi Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Insomnia Drug: suvorexant Other: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 17, 2017
Actual Primary Completion Date : October 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Suvorexant

Arm Intervention/treatment
Experimental: suvorexant
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) in oral administration, once daily before bedtime; Treatment duration: 2 weeks
Drug: suvorexant
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
Other Name: Belsomra

Placebo Comparator: placebo
Placebo in oral administration, once daily before bedtime; Treatment duration: 2 weeks.
Other: Placebo
Placebo once daily before bedtime.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

[At interim registration]

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

  1. Patients who give written consent of agreement to voluntarily participation in the clinical study
  2. Age 20 years or older
  3. Sex: Male or female
  4. Treatment classification: Outpatient
  5. Hypertensive patient who meet at least one of the following:

    • Under antihypertensive medications
    • Clinic systolic blood pressure (SBP) less than 160 mmHg
  6. 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:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849184


Locations
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Japan
Takahira Internal Medicine Clinic
Fukuoka, Japan
Yamasaki family clinic
Hyogo, Japan
Yagi hospital
Tokyo, Japan
Sponsors and Collaborators
Jichi Medical University
Merck Sharp & Dohme Corp.
Satt Co.,Ltd
Investigators
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Principal Investigator: Kazuomi Kario, MD, PhD Jichi Medical University School of Medicine
  Study Documents (Full-Text)

Documents provided by Kazuomi Kario, Jichi Medical University:

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Responsible Party: Kazuomi Kario, Professor & Chairman, Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University
ClinicalTrials.gov Identifier: NCT02849184     History of Changes
Other Study ID Numbers: 4305-063
First Posted: July 29, 2016    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action