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

NCT02849184 | Completed Phase 4 Results DMC

• 1 other identifier: 4305-063
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Morning Systolic Blood Pressure Variability

  2 weeks

• Changes in the Total Sleep Time

  2 weeks

• Changes in the Time to Sleep Onset

  2 weeks

• Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction

  2 weeks

• Change in Urinary Albumin-to-creatinine Ratio (UACR)

  2 weeks

Study Arms (2)

suvorexant

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

suvorexant DRUG

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

Also known as: Belsomra

suvorexant

Placebo OTHER

Placebo once daily before bedtime.

placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[At interim registration\]
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jichi Medical University: lead
• Merck Sharp & Dohme LLC: collaborator
• Satt Co.,Ltd: collaborator

Study Sites (3)

Takahira Internal Medicine Clinic

Fukuoka, Japan

Location

Yamasaki family clinic

Hyōgo, Japan

Location

Yagi hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertension; Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Professor Kazuomi Kario
• Organization: Jichi Medical University School of Medicine

kkario@jichi.ac.jp

+81-285-58-7538

Study Officials

• Kazuomi Kario, MD, PhD

  Jichi Medical University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chairman, Division of Cardiovascular Medicine, Department of Medicine

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 29, 2016
• Study Start: January 17, 2017
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)