A Study of CIN-107 in Patients With Uncontrolled Hypertension
NCT ID: NCT05137002
Last Updated: 2023-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
249 participants
INTERVENTIONAL
2021-12-07
2022-10-10
Brief Summary
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Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.
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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 0.5 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
CIN-107
CIN-107 tablets by mouth once daily
CIN-107 1 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
CIN-107
CIN-107 tablets by mouth once daily
CIN-107 2 mg
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control
CIN-107
CIN-107 tablets by mouth once daily
Placebo
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks
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
* Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
* Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
* If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
* Agrees to comply with the contraception and reproduction restrictions of the study;
Exclusion Criteria
* Has a body mass index (BMI) \>50 kg/m2;
* Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
* Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
* Has documented estimated eGFR \<30 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;
* Major cardiac surgery within 6 months before Screening;
* Has chronic permanent atrial fibrillation;
* Has uncontrolled diabetes with glycated hemoglobin \>10% at Screening;
* Has planned dialysis or kidney transplantation planned during the course of the study;
* Prior solid organ transplant and/or cell transplants;
* Sodium \<130 mEq/L;
* Potassium \<3.5 mEq/L;
* Potassium \>5 mEq/L;
* White blood cell count \>15 × E9/L or absolute neutrophil count \<1 × E9/L at Screening;
* 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 27
Saraland, Alabama, United States
CinCor Site 35
Tucson, Arizona, United States
CinCor Site 69
Encinitas, California, United States
CinCor Site 6
Lincoln, California, United States
CinCor Site 20
Los Angeles, California, United States
CinCor Site 70
Lynwood, California, United States
CinCor Site 36
Northridge, California, United States
CinCor Site 29
Oceanside, California, United States
CinCor Site 46
Panorama City, California, United States
CinCor Site 47
San Dimas, California, United States
CinCor Site 49
Santa Ana, California, United States
CinCor Site 52
West Hills, California, United States
CinCor Site 57
Denver, Colorado, United States
CinCor Site 31
Waterbury, Connecticut, United States
CinCor Site 18
Clearwater, Florida, United States
CinCor Site 41
Cooper City, Florida, United States
CinCor Site 28
Homestead, Florida, United States
CinCor Site 9
Jupiter, Florida, United States
CinCor Site 1
Lake Worth, Florida, United States
CinCor Site 12
Miami, Florida, United States
CinCor Site 54
Miami, Florida, United States
CinCor Site 13
Miami, Florida, United States
CinCor Site 17
Miami, Florida, United States
CinCor Site 16
Tampa, Florida, United States
CinCor Site 34
Winter Haven, Florida, United States
CinCor Site 14
Buford, Georgia, United States
CinCor Site 33
Addison, Illinois, United States
CinCor Site 40
Chicago, Illinois, United States
CinCor Site 42
Gurnee, Illinois, United States
CinCor Site 50
Morton, Illinois, United States
CinCor Site 72
Brownsburg, Indiana, United States
CinCor Site 63
West Des Moines, Iowa, United States
CinCor Site 7
Lexington, Kentucky, United States
CinCor Site 21
Louisville, Kentucky, United States
CinCor Site 30
Marrero, Louisiana, United States
CinCor Site 59
Metairie, Louisiana, United States
CinCor Site 19
New Orleans, Louisiana, United States
CinCor Site 25
Shreveport, Louisiana, United States
CinCor Site 38
Elkridge, Maryland, United States
CinCor Site 38
Elkridge, Maryland, United States
CinCor Site 22
Troy, Michigan, United States
CinCor Site 64
Olive Branch, Mississippi, United States
CinCor Site 11
Brooklyn, New York, United States
CinCor Site 65
Staten Island, New York, United States
CinCor Site 15
Cincinnati, Ohio, United States
CinCor Site 24
Columbus, Ohio, United States
CinCor Site 4
Dayton, Ohio, United States
CinCor Site 43
Oklahoma City, Oklahoma, United States
CinCor Site 60
Chattanooga, Tennessee, United States
CinCor Site 48
Austin, Texas, United States
CinCor Site 32
Carrollton, Texas, United States
CinCor Site 68
Dallas, Texas, United States
CinCor Site 61
Georgetown, Texas, United States
CinCor Site 55
Houston, Texas, United States
CinCor Site 3
Houston, Texas, United States
CinCor Site 58
Katy, Texas, United States
CinCor Site 62
Lampasas, Texas, United States
CinCor Site 26
McAllen, Texas, United States
CinCor Site 53
San Antonio, Texas, United States
CinCor Site 10
Sugar Land, Texas, United States
CinCor Site 45
Salt Lake City, Utah, United States
CinCor Site 2
Manassas, Virginia, United States
CinCor Site 5
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CIN-107-124
Identifier Type: -
Identifier Source: org_study_id
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