Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Lorundrostat then Placebo | Experimental |
| |
| Sequence 2: Placebo then Lorundrostat | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorundrostat | Drug | Lorundrostat tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-adjusted Change From Baseline in AHI at Week 4 | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-adjusted Change From Baseline in Nighttime Average Systolic Blood Pressure (SBP) at Week 4 | Baseline, Week 4 | |
| Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) SBP at Week 4 | Baseline, Week 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama | Tuscaloosa | Alabama | 35401 | United States | ||
| Chandler Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Lorundrostat matching placebo tablet. |
|
| Placebo-adjusted Change From Baseline in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) at Week 4 | Baseline, Week 4 |
| Placebo-adjusted Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 4 | Baseline, Week 4 |
| Placebo-adjusted Change From Baseline in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) at Week 4 | Baseline, Week 4 |
| Placebo-adjusted Change From Baseline in PROMIS Sleep-Related Impairment (SRI) at Week 4 | Baseline, Week 4 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Preferred Research Partners Inc. | Little Rock | Arkansas | 72211 | United States |
| Orange County Research Institute | Anaheim | California | 92801 | United States |
| The Neurology Center of Southern California - Profound Research, LLC | Carlsbad | California | 92011 | United States |
| Probe Clinical Research Corporation | Riverside | California | 92501 | United States |
| Research Carolina Elite | Denver | Colorado | 28037 | United States |
| Nouvelle Clinical Research | Cutler Bay | Florida | 33189 | United States |
| Arrow Clinical Trials | Daytona Beach | Florida | 32117 | United States |
| PharmaDev Clinical Research Institute, LLC | Miami | Florida | 33176 | United States |
| CNS Healthcare - Orlando (Clinical Neuroscience Solutions) | Orlando | Florida | 32801 | United States |
| NeuroTrials Research Inc | Atlanta | Georgia | 30328 | United States |
| Centricity Research Rincon Pulmonology | Rincon | Georgia | 31326 | United States |
| Chicago Research Center Inc | Chicago | Illinois | 60634 | United States |
| Centennial Medical Group | Columbia | Maryland | 21045 | United States |
| Velocity Clinical Research, Rockville | Rockville | Maryland | 20854 | United States |
| Henry Ford Health System/Henry Ford Medical Center - Columbus | Novi | Michigan | 48377 | United States |
| Revive Research Institute, Inc | Southfield | Michigan | 48075 | United States |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63123 | United States |
| Patient First MD | Middletown | New Jersey | 07748 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Northwest Research Center | Portland | Oregon | 97202 | United States |
| CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis) | Memphis | Tennessee | 38119 | United States |
| Huntsville Research Institute LLC | Huntsville | Texas | 77340 | United States |
| Sleep Therapy Research Center | San Antonio | Texas | 78229 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006973 | Hypertension |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided