A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
NCT ID: NCT04519658
Last Updated: 2023-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
275 participants
INTERVENTIONAL
2020-10-12
2022-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CIN-107 0.5mg
Subjects received CIN-107 0.5 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
CIN-107
CIN-107 tablets by mouth once daily
CIN-107 1mg
Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
CIN-107
CIN-107 tablets by mouth once daily
CIN-107 2mg
Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
CIN-107
CIN-107 tablets by mouth once daily
Placebo
Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Placebo
placebo tablets by mouth once daily
Interventions
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CIN-107
CIN-107 tablets by mouth once daily
Placebo
placebo tablets by mouth once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be at least 70% compliant to their anti-hypertensive medication regimen;
* Has a seated BP ≥ 130/80 mmHg;
* Agrees to comply with the contraception and reproduction restrictions of the study; and
* Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.
Exclusion Criteria
* Has a body mass index (BMI) \> 40 kg/m2;
* Has an upper arm circumference \< 7 or \> 17 inches;
* Has been on night shifts at any time during the 4 weeks before Screening;
* Is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache);
* Is not willing or not able to discontinue an MRA or a potassium sparing diuretic as part of an existing antihypertensive regimen;
* Is not willing or not able to discontinue taking a potassium supplement;
* Has documented estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m2
* Has known and documented New York Heart Association stage III or IV chronic heart failure
* Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before Screening;
* Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram;
* Major cardiac surgery (eg, CABG, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
* Has chronic permanent atrial fibrillation;
* Has uncontrolled diabetes with glycosylated hemoglobin \> 9.5% at Screening;
* Has planned dialysis or kidney transplant during the course of this study;
* Potassium \< 3.5 mEq/L;
* Potassium \> 5.0 mEq/L;
* Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
* Has typical consumption of ≥14 alcoholic drinks weekly.
18 Years
ALL
No
Sponsors
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CinCor Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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CinCor Site 16
Birmingham, Alabama, United States
CinCor Site 38
Birmingham, Alabama, United States
CinCor Site 61
Saraland, Alabama, United States
CinCor Site 90
Tucson, Arizona, United States
CinCor Site 82
Anaheim, California, United States
CinCor Site 91
Granada Hills, California, United States
CinCor Site 25
Lincoln, California, United States
CinCor Site 73
Los Angeles, California, United States
CinCor Site 36
Los Angeles, California, United States
CinCor Site 34
Lynwood, California, United States
CinCor Site 14
San Dimas, California, United States
CinCor Site 28
Santa Ana, California, United States
CinCor Site 19
Spring Valley, California, United States
CinCor Site 32
Tustin, California, United States
CinCor Site 44
West Hills, California, United States
CinCor Site 66
Whittier, California, United States
CinCor Site 56
Stamford, Connecticut, United States
CinCor Site 30
Clearwater, Florida, United States
CinCor Site 13
Fort Myers, Florida, United States
CinCor Site 74
Hialeah, Florida, United States
CinCor Site 22
Homestead, Florida, United States
CinCor Site 20
Jacksonville, Florida, United States
CinCor Site 1
Jupiter, Florida, United States
CinCor Site 84
Lake Worth, Florida, United States
CinCor Site 70
Miami, Florida, United States
CinCor Site 89
Miami, Florida, United States
CinCor Site 94
Miami, Florida, United States
CinCor Site 5
Port Orange, Florida, United States
CinCor Site 9
St. Petersburg, Florida, United States
CinCor Site 23
Tampa, Florida, United States
CinCor Site 88
Winter Haven, Florida, United States
CinCor Site 71
Suwanee, Georgia, United States
CinCor Site 11
Meridian, Idaho, United States
CinCor Site 15
Addison, Illinois, United States
CinCor Site 81
Arlington Heights, Illinois, United States
CinCor Site 49
Chicago, Illinois, United States
CinCor Site 35
Morton, Illinois, United States
CinCor Site 58
Evansville, Indiana, United States
CinCor Site 54
West Des Moines, Iowa, United States
CinCor Site 29
Lexington, Kentucky, United States
CinCor Site 24
Lexington, Kentucky, United States
CinCor Site 69
New Orleans, Louisiana, United States
CinCor Site 64
Shreveport, Louisiana, United States
CinCor Site 75
Baltimore, Maryland, United States
CinCor Site 65
Elkridge, Maryland, United States
CinCor Site 52
Roseville, Michigan, United States
CinCor Site 21
Troy, Michigan, United States
CinCor Site 92
Hattiesburg, Mississippi, United States
CinCor Site 50
Olive Branch, Mississippi, United States
CinCor Site 45
Butte, Montana, United States
CinCor Site 47
Las Vegas, Nevada, United States
CinCor Site 31
Albuquerque, New Mexico, United States
CinCor Site 55
Johnson City, New York, United States
CinCor Site 4
The Bronx, New York, United States
CinCor Site 59
Cincinnati, Ohio, United States
CinCor Site 6
Cincinnati, Ohio, United States
CinCor Site 7
Cincinnati, Ohio, United States
CinCor Site 86
Dayton, Ohio, United States
CinCor Site 43
Beaver, Pennsylvania, United States
CinCor Site 39
Myrtle Beach, South Carolina, United States
CinCor Site 97
Jackson, Tennessee, United States
CinCor Site 42
Knoxville, Tennessee, United States
CinCor Site 27
Austin, Texas, United States
CinCor Site 80
Carrollton, Texas, United States
CinCor Site 79
Dallas, Texas, United States
CinCor Site 87
Friendswood, Texas, United States
CinCor Site 2
Houston, Texas, United States
CinCor Site 72
Houston, Texas, United States
CinCor Site 46
Hurst, Texas, United States
CinCor Site 93
Kerville, Texas, United States
CinCor Site 37
McAllen, Texas, United States
CinCor Site 85
Sugar Land, Texas, United States
CinCor Site 48
Draper, Utah, United States
CinCor Site 3
Salt Lake City, Utah, United States
CinCor Site 77
Alexandria, Virginia, United States
CinCor Site 8
Burke, Virginia, United States
CinCor Site 33
Manassas, Virginia, United States
CinCor Site 76
Norfolk, Virginia, United States
CinCor Site 41
Olympia, Washington, United States
CinCor Site 51
Kenosha, Wisconsin, United States
Countries
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References
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Freeman MW, Halvorsen YD, Marshall W, Pater M, Isaacsohn J, Pearce C, Murphy B, Alp N, Srivastava A, Bhatt DL, Brown MJ; BrigHTN Investigators. Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension. N Engl J Med. 2023 Feb 2;388(5):395-405. doi: 10.1056/NEJMoa2213169. Epub 2022 Nov 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CIN-107-121
Identifier Type: -
Identifier Source: org_study_id
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