A Study of CIN-107 in Adults With Primary Aldosteronism
Study Details
Study Description
Brief Summary
This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment, at doses from 2 to 8 mg per day, for the management of blood pressure in patients with primary aldosteronism (PA).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CIN-107 for dosing at 2, 4, or 8 mg Patients will be provided with an initial dose of CIN-107 and start once daily (QD) dosing of CIN-107 tablets at 2 mg. At Visit 4, CIN-107 dose may be up-titrated to 4 mg QD if the patient has tolerated dosing of CIN-107 at 2 mg and the blood pressure (BP) records indicate minimal hypotension risk. At Visit 5, CIN-107 dose may be up-titrated to 8 mg QD if the patient has tolerated dosing of CIN-107 at 4 mg. |
Drug: CIN-107 2 mg dosing
One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.
Drug: CIN-107 4 mg dosing
Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.
Drug: CIN-107 8 mg dosing
Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.
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Outcome Measures
Primary Outcome Measures
- Number of participants with Adverse Events (AEs) [14 Weeks]
Outcome measure is overall safety with is a composite of the following individual parameters (unit of measure in brackets): Adverse Events [number of events]; ECGs [PR interval (msec), RR interval (msec), or QTcF interval (msec); clinically significant ECG findings that are detected during the study will be reported as adverse events]; Hematology and chemistry laboratory values [clinically significant abnormal laboratory findings that are detected during the study will be reported as adverse events]; Vital signs [pulse, temperature, heart rate and blood pressure] and physical examination data changes noted as clinically significant abnormalities that arise during the study will be recorded as adverse events
- Change in mean seated systolic blood pressure (SBP) [12 weeks]
Secondary Outcome Measures
- Change in mean diastolic blood pressure (DBP) [12 Weeks]
- The percentage of patients achieving a seated blood pressure (BP) response <140/90 mmHg [Within 10 min after drug administration, for at least 4 weeks]
- The percentage of patients achieving a seated BP response <130/80 mmHg [Within 10 min after drug administration, for at least 4 weeks]
- The percentage of patients achieving either: - a plasma aldosterone concentration (PAC) < 15 ng/dL and a plasma renin activity (PRA) ≥ 0.5 ng/mL/h; or - an ARR < 15; or - unsuppressed renin activity PRA ≥ 1.0 ng/mL/h [12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have been diagnosed with PA.
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Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment.
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Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
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Are willing to be compliant with the contraception and reproduction restrictions of the study.
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Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are newly diagnosed with PA and have not taken an MRA in the past 12 weeks.
Exclusion Criteria:
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At Screening Visit, have a single occurrence of mean seated SBP > 180 mmHg or DBP > 110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg if currently taking an MRA.
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Have a body mass index > 45 kg/m2.
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Have had a previous surgical intervention for an adrenal adenoma or have a planned adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
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Have a documented estimated glomerular filtration rate < 45 mL/min/1.73 m2.
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Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.
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Have known documented New York Heart Association class III or IV chronic heart failure.
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Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.
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Have known current severe left ventricular outflow obstruction.
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Have had major cardiac surgery within 6 months before the Screening Visit.
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Have a history of, or currently experiencing, clinically significant arrhythmias.
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Have had a prior solid organ transplant or cell transplant.
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Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
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Have typical consumption of > 14 alcoholic drinks weekly.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | CinCor Site 16 | Los Angeles | California | United States | 90048 |
2 | CinCor Site 03 | San Francisco | California | United States | 94110 |
3 | CinCor Site 10 | Stanford | California | United States | 94305 |
4 | CinCor Site 12 | Chicago | Illinois | United States | 60611 |
5 | CinCor Site 04 | Baltimore | Maryland | United States | 21287 |
6 | CinCor Site 02 | Ann Arbor | Michigan | United States | 48109 |
7 | CinCor Site 01 | Rochester | Minnesota | United States | 55905 |
8 | CinCor Site 09 | Columbus | Ohio | United States | 43210 |
9 | CinCor Site 17 | Dallas | Texas | United States | 75309 |
Sponsors and Collaborators
- CinCor Pharma, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIN-107-122