Clinical trial NCT02849184: To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Insomnia
Lead sponsor: Jichi Medical University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Satt Co.,Ltd
First posted: 2016-07-29
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Change in Sleep Systolic Blood Pressure
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in Morning Systolic Blood Pressure Variability
timeFrame: 2 weeks
measure: Changes in the Total Sleep Time
timeFrame: 2 weeks
measure: Changes in the Time to Sleep Onset
timeFrame: 2 weeks
measure: Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction
timeFrame: 2 weeks
measure: Change in Urinary Albumin-to-creatinine Ratio (UACR)
timeFrame: 2 weeks
measure: Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction
timeFrame: 2 weeks
measure: Change in NT-proBNP
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Takahira Internal Medicine Clinic
city: Hyogo
country: Japan
facility: Yamasaki family clinic
city: Tokyo
country: Japan
facility: Yagi hospital
Study officials:
affiliation: Jichi Medical University School of Medicine
name: Kazuomi Kario, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: