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Trial record 1 of 1 for:    cin-107-124
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A Study of CIN-107 in Patients With Uncontrolled Hypertension (HALO)

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ClinicalTrials.gov Identifier: NCT05137002
Recruitment Status : Recruiting
First Posted : November 30, 2021
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
CinCor Pharma, Inc.

Brief Summary:
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of CIN-107 in the treatment of patients with uncontrolled hypertension.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Drug: CIN-107 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : September 6, 2022
Estimated Study Completion Date : September 6, 2022

Resource links provided by the National Library of Medicine


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

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

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

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 :
  1. Change from baseline in mean seated systolic BP (SBP) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in mean seated diastolic BP (DBP) [ Time Frame: 8 weeks ]
  2. Change from baseline in 24-hour urine aldosterone and serum aldosterone [ Time Frame: 8 weeks ]
  3. Percentage of patients achieving a mean seated SBP <130 mmHg [ Time Frame: 8 weeks ]
  4. Change from baseline in 24-hour urine renin and serum renin [ Time Frame: 8 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:

  • Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
  • Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHG;
  • Demonstrates they are able to be adherent to the study drug and their anti-hypertensive medication during a run-in period
  • If taking 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 mean seated systolic blood pressure (SBP) ≥180 mmHG;
  • 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 glycosylated 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;

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): NCT05137002


Contacts
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Contact: Enion Hampton 6105924222 ehampton@cincor.com

Locations
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Sponsors and Collaborators
CinCor Pharma, Inc.
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Responsible Party: CinCor Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05137002    
Other Study ID Numbers: CIN-107-124
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases