A multi-center, double-blind, randomized, parallel design study to compare the effectiveness of suvorexant versus placebo on sleep pressure and circadian rhythm in insomniacs with hypertension: The Super 1 study

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000023389
• Date of registration: 12/08/2016
• Prospective Registration: Yes
• Primary sponsor: Jichi Medical University School of Medicine
• Public 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 insomniacs with hypertension: The Super 1 study
• Scientific 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 insomniacs with hypertension: The Super 1 study - A multi-center, double-blind, randomized, parallel design study to compare the effectiveness of suvorexant versus placebo on sleep pressure and circadian rhythm in insomniacs with hypertension: The Super 1 study
• Date of first enrolment: 2017/01/17
• Target sample size: 80
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026687
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Secretariat
• Affiliation: Satt Co., Ltd. Clinical research steering group

• Name: Kazuomi Kario
• Affiliation: Jichi Medical University School of Medicine Division of Cardiovascular Medicine, Department of Medicine,

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Insomnia with hypertensive symptoms

Intervention(s)

During the treatment period (2 weeks), the patients will orally receive suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
During the treatment period (2 weeks), the patients will orally receive placebo once daily before bedtime.

Primary Outcome(s)

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

Secondary Outcome(s)

Secondary endpoints: 1. To compare the percent change from non-dippers to dippers. 2. To compare the efficacy of suvorexant versus placebo on the reduction of morning SBP by ABPM and HBPM. 3. To compare the efficacy of suvorexant versus placebo on the reduction of morning SBP variability by ABPM and HBPM. 4. Changes in the total sleep time (TST) (self-reported). 5. Changes in the time to sleep onset (TSO) (self-reported). 6. To study the correlation of changes of sleep BP parameters with changes of sleep quality parameters 7. To study the correlation of changes of urinary albumin-to-creatinine ratio (UACR) / NT-proBNP.

Source(s) of Monetary Support

MSD K.K.

Ethics review

Status: YES
Approval date:
Contact: