A Study of CIN-107 in Patients With Uncontrolled Hypertension

NCT05137002
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Phase
Phase 2
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Recruitment status
Completed
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Participants
249
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Lead sponsor
CinCor Pharma, Inc.
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Start date
2021-12-07
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Number of sites
63
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Summary
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications. 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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Acronym
HALO
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Short title
A Study of CIN-107 in Patients With Uncontrolled Hypertension
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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
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2022-10-10
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First posted
2021-11-30
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Registry last updated
2023-08-01
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Primary completion date
2022-09-13
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Start date
2021-12-07
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Actual participants
249
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Participants
249
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
63
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
CinCor Pharma, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05137002
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ClinicalTrials.gov ID
NCT05137002
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change From Baseline in Mean Seated Systolic BP (SBP)

    Timeframe: 8 weeks

    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).

  1. Change From Baseline in Mean Seated Diastolic BP (DBP)

    Timeframe: 8 weeks

    The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)

  2. Change From Baseline in 24-hour Urine Aldosterone

    Timeframe: 8 weeks

    The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)

  3. Change From Baseline in 24-hour Serum Aldosterone

    Timeframe: 8 weeks

    The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)

  4. Percentage of Patients Achieving a Mean Seated SBP <130 mmHg

    Timeframe: 8 weeks

    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)

  5. Change From Baseline in 24-hour Urine Renin

    Timeframe: 8 weeks

    The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)

  6. Change From Baseline in 24-hour Serum Renin

    Timeframe: 8 weeks

    The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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 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;

  • 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 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;
Sources for eligibility
clinicaltrials.gov

  • CinCor Site 27Saraland, United States
  • CinCor Site 35Tucson, United States
  • CinCor Site 69Encinitas, United States
  • CinCor Site 6Lincoln, United States
  • CinCor Site 20Los Angeles, United States
  • CinCor Site 70Lynwood, United States
  • CinCor Site 36Northridge, United States
  • CinCor Site 29Oceanside, United States
  • CinCor Site 46Panorama City, United States
  • CinCor Site 47San Dimas, United States
  • CinCor Site 49Santa Ana, United States
  • CinCor Site 52West Hills, United States
  • CinCor Site 57Denver, United States
  • CinCor Site 31Waterbury, United States
  • CinCor Site 18Clearwater, United States
  • CinCor Site 41Cooper City, United States
  • CinCor Site 28Homestead, United States
  • CinCor Site 9Jupiter, United States
  • CinCor Site 1Lake Worth, United States
  • CinCor Site 12Miami, United States
  • CinCor Site 54Miami, United States
  • CinCor Site 13Miami, United States
  • CinCor Site 17Miami, United States
  • CinCor Site 16Tampa, United States
  • CinCor Site 34Winter Haven, United States

And 38 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)