The primary purpose of the study is to assess the effect of lorundrostat taken orally (po) once a day on the Apnea-Hypopnea Index (AHI) in participants with moderate to severe obstructive sleep apnea (OSA) and hypertension.
The study is a randomized, double-blind (DB), placebo controlled, crossover study. A 4-week screening period is followed by two DB 4-week treatment periods separated by a 2-week washout period. Participants must be 18 to 75 years old with moderate to severe OSA, hypertension and meet all applicable eligibility criteria. Participants who are medically prescribed and deemed compliant with positive airway pressure (PAP) therapy for greater than or equal to (\>=) 4 hours per night (Continuous PAP \[CPAP\], or automatic PAP \[autoPAP\]) and for at least 3 months prior to the study enrollment are eligible for the study. Participants on PAP therapy should comply with PAP therapy for the duration of the study. Participants who are not currently on PAP therapy and not anticipated to start PAP for the duration of the study, are also eligible for the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Lorundrostat tablet.
Lorundrostat matching placebo tablet.
Placebo-adjusted Change From Baseline in AHI at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Nighttime Average Systolic Blood Pressure (SBP) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) SBP at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in PROMIS Sleep-Related Impairment (SRI) at Week 4
Time frame: Baseline, Week 4
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