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Trial record 1 of 1 for:    cin-107 | Primary Aldosteronism
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A Study of CIN-107 in Adults With Primary Aldosteronism

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ClinicalTrials.gov Identifier: NCT04605549
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
CinCor Pharma, Inc.

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
Primary Aldosteronism Hyperaldosteronism Drug: CIN-107 2 mg dosing Drug: CIN-107 4 mg dosing Drug: CIN-107 8 mg dosing Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Effectiveness of CIN-107 for the Management of Blood Pressure in Patients With Primary Aldosteronism
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) [ Time Frame: 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

  2. Change in mean seated systolic blood pressure (SBP) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in mean diastolic blood pressure (DBP) [ Time Frame: 12 Weeks ]
  2. The percentage of patients achieving a seated blood pressure (BP) response <140/90 mmHg [ Time Frame: Within 10 min after drug administration, for at least 4 weeks ]
  3. The percentage of patients achieving a seated BP response <130/80 mmHg [ Time Frame: Within 10 min after drug administration, for at least 4 weeks ]
  4. 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 [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have been diagnosed with PA.
  2. Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment.
  3. Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
  4. Are willing to be compliant with the contraception and reproduction restrictions of the study.
  5. 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:

  1. 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.
  2. Have a body mass index > 45 kg/m2.
  3. 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.
  4. Have a documented estimated glomerular filtration rate < 45 mL/min/1.73 m2.
  5. Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.
  6. Have known documented New York Heart Association class III or IV chronic heart failure.
  7. Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.
  8. Have known current severe left ventricular outflow obstruction.
  9. Have had major cardiac surgery within 6 months before the Screening Visit.
  10. Have a history of, or currently experiencing, clinically significant arrhythmias.
  11. Have had a prior solid organ transplant or cell transplant.
  12. Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
  13. Have typical consumption of > 14 alcoholic drinks weekly.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605549


Contacts
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Contact: CinCor Pharma Clinical Trials Contact 617-675-8126 info@cincor.com

Locations
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United States, California
CinCor Site 16 Not yet recruiting
Los Angeles, California, United States, 90048
CinCor Site 03 Not yet recruiting
San Francisco, California, United States, 94110
CinCor Site 10 Not yet recruiting
Stanford, California, United States, 94305
United States, Illinois
CinCor Site 12 Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Maryland
CinCor Site 04 Recruiting
Baltimore, Maryland, United States, 21287
United States, Michigan
CinCor Site 02 Not yet recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
CinCor Site 01 Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Ohio
CinCor Site 09 Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
CinCor Site 17 Not yet recruiting
Dallas, Texas, United States, 75309
Sponsors and Collaborators
CinCor Pharma, Inc.
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Responsible Party: CinCor Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04605549    
Other Study ID Numbers: CIN-107-122
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CinCor Pharma, Inc.:
Primary Aldosteronism
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases