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    The study has expanded to include 63 locations, and the revision has been updated from v2.9.7 to v2.10.0.
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    Summary
    The value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less MedlinePlus Genetics related topics: Hypertension MedlinePlus related topics: High Blood Pressure FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : 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 Drug : CIN-107 CIN-107 tablets by mouth once daily Other Names: Baxdrostat Experimental : 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 Drug : CIN-107 CIN-107 tablets by mouth once daily Other Names: Baxdrostat Experimental : 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 Drug : CIN-107 CIN-107 tablets by mouth once daily Other Names: Baxdrostat Placebo Comparator : 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 Drug : Placebo Placebo tablets by mouth once daily Primary Outcome Measures Outcome Measure Measure Description Time Frame Change From Baseline in Mean Seated Systolic BP (SBP) The primary efficacy endpoint was the change from baseline in mean seated SBP after 8 weeks of treatment in patients with uncontrolled HTN (Part 1). 8 weeks Secondary Outcome Measures Outcome Measure Measure Description Time Frame Change From Baseline in Mean Seated Diastolic BP (DBP) The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) 8 weeks Change From Baseline in 24-hour Urine Aldosterone The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1) 8 weeks Change From Baseline in 24-hour Serum Aldosterone The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1) 8 weeks Percentage of Patients Achieving a Mean Seated SBP <130 mmHg The percentage of patients achieving a mean seated SBP <130 mmHg ('responders') with CIN-107 compared to placebo after 8 weeks of treatment (Part 1; Weeks 1 to 8) 8 weeks Change From Baseline in 24-hour Urine Renin The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) 8 weeks Change From Baseline in 24-hour Serum Renin The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) 8 weeks Additional Relevant MeSH Terms Vascular Diseases Cardiovascular Diseases Hypertension Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Study Documents Provided by CinCor Pharma, Inc. Study Protocol [ PDF , 12MB, 2022-02-25 ] Statistical Analysis Plan [ PDF , 6.68MB, 2022-10-07 ] Revision: v2.9.1' represents the recent change on the webpage.
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    Check dated 2024-06-25T08:28:28.000Z thumbnail image

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