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
- Conditions
- Insomnia with hypertensive symptoms
- Registration Number
- JPRN-UMIN000023389
- Lead Sponsor
- Jichi Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method