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The main purpose of the study is to evaluate the efficacy of selnoflast compared with placebo in participants with atherosclerosis, at high-risk for major adverse cardiovascular event (MACE), who are currently on standard-of-care (SOC) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selnoflast | Experimental | Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo, PO, BID for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selnoflast | Drug | Selnoflast will be administered as per the schedule specified in the respective arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From Baseline to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L]) | hsCRP=high-sensitivity C-reactive protein. | Baseline up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L) | Baseline and Week 12 | |
| Change From Baseline in mdsTBR of Carotids at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L) | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GC46102 https://forpatients.roche.com/ | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Research Foundation of Southern California | Recruiting | Beverly Hills | California | 90210 | United States |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Placebo | Drug | Placebo will be administered as per the schedule specified in the respective arm. |
|
| Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L) | Baseline and Week 12 |
| Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L) | Baseline and Week 12 |
| Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L) | Baseline and Week 12 |
| Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the NCI CTCAE v5.0 Grading Scale | NCI CTCAE v5.0 = National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0. | Up to approximately 20 weeks |
| Plasma Concentration of Selnoflast at Specified Timepoints | Up to 12 weeks |
| National Heart Institute | Recruiting | Beverly Hills | California | 90211 | United States |
| Amnova Clinical Research | Recruiting | Irvine | California | 92604 | United States |
| Alliance Clinical West Hills (Focus Clinical Research) | Recruiting | West Hills | California | 91307 | United States |
| Inpatient Research Clinic (Las Palmas Medical Research Center) | Recruiting | Miami Lakes | Florida | 33014 | United States |
| Asha Clinical Research-Munster,Llc | Recruiting | Hammond | Indiana | 46324 | United States |
| Profound Research LLC at Cardiology and Vascular Associates - CAVA | Recruiting | Bloomfield Hills | Michigan | 48304 | United States |
| Profound Research LLC at Millenium Cardiology | Recruiting | Farmington Hills | Michigan | 48334 | United States |
| Ahmed Arif Medical Research Center (AA MRC LLC ) | Recruiting | Flint | Michigan | 48504 | United States |
| DiGiovanna Inst for Med Ed&Res | Recruiting | North Massapequa | New York | 11758-1802 | United States |
| Preferred Primary Care Physicians, Inc | Recruiting | Pittsburgh | Pennsylvania | 15243 | United States |
| Southwest Family Medicine Associates | Recruiting | Dallas | Texas | 75235 | United States |
| East Texas Cardiology PA | Not yet recruiting | Houston | Texas | 77002 | United States |
| Cardiovascular Specialists of Willowbrook | Recruiting | Houston | Texas | 77070 | United States |
| Eastside Research Associates, LLC dba Era Health Research | Recruiting | Redmond | Washington | 98036 | United States |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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