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

Hypertension Clinical Trial

— Super1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849184
• Other study ID #: 4305-063
• Status: Completed
• Phase: Phase 4
• Start date: January 17, 2017
• Est. completion date: March 2018

Study information

• Verified date: June 2019
• Source: Jichi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Other:
• Placebo
Placebo once daily before bedtime.

Locations

Country	Name	City	State
Japan	Takahira Internal Medicine Clinic	Fukuoka
Japan	Yamasaki family clinic	Hyogo
Japan	Yagi hospital	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
Jichi Medical University	Merck Sharp & Dohme Corp., Satt Co.,Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Systolic Blood Pressure	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	2 weeks
Secondary	Change in Morning Systolic Blood Pressure Variability	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 weeks
Secondary	Changes in the Total Sleep Time	Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0	2 weeks
Secondary	Changes in the Time to Sleep Onset	Time to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0	2 weeks
Secondary	Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction	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).	2 weeks
Secondary	Change in Urinary Albumin-to-creatinine Ratio (UACR)	Percentage change in UACR from baseline to 2 weeks	2 weeks
Secondary	Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction	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).	2 weeks
Secondary	Change in NT-proBNP	Percentage change in NT-proBNP from baseline to 2 weeks	2 weeks