Clinical trial NCT04519658: A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 12 Weeks of Treatment in Patients With Treatment-Resistant Hypertension (rHTN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Resistant Hypertension
Lead sponsor: CinCor Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study to evaluate the efficacy and safety of CIN-107 as compared to placebo after 12 weeks of treatment in patients with treatment-resistant hypertension (rHTN).


Eligibility criteria: Inclusion Criteria:

* Is on a stable regimen of ≥ 3 antihypertensive agents (one of which is a diuretic) for at least 4 weeks prior to randomization;
* Be at least 70% compliant to their anti-hypertensive medication regimen;
* Has a seated BP ≥ 130/80 mmHg;
* Agrees to comply with the contraception and reproduction restrictions of the study; and
* Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

* Has a seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;
* Has a body mass index (BMI) \> 40 kg/m2;
* Has an upper arm circumference \< 7 or \> 17 inches;
* Has been on night shifts at any time during the 4 weeks before Screening;
* Is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache);
* Is not willing or not able to discontinue an MRA or a potassium sparing diuretic as part of an existing antihypertensive regimen;
* Is not willing or not able to discontinue taking a potassium supplement;
* Has documented estimated glomerular filtration rate (eGFR) \< 45 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;
* Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram;
* Major cardiac surgery (eg, CABG, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
* Has chronic permanent atrial fibrillation;
* Has uncontrolled diabetes with glycosylated hemoglobin \> 9.5% at Screening;
* Has planned dialysis or kidney transplant during the course of this study;
* Potassium \< 3.5 mEq/L;
* Potassium \> 5.0 mEq/L;
* Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
* Has typical consumption of ≥14 alcoholic drinks weekly.

Primary outcomes:
measure: Change From Baseline in Mean Seated Systolic BP (SBP)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Seated Diastolic BP (DBP)
timeFrame: 12 weeks
measure: The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: CinCor Site 16
state: Alabama
city: Birmingham
country: United States
facility: CinCor Site 38
state: Alabama
city: Saraland
country: United States
facility: CinCor Site 61
state: Alabama
city: Tucson
country: United States
facility: CinCor Site 90
state: Arizona
city: Anaheim
country: United States
facility: CinCor Site 82
state: California
city: Granada Hills
country: United States
facility: CinCor Site 91
state: California
city: Lincoln
country: United States
facility: CinCor Site 25
state: California
city: Los Angeles
country: United States
facility: CinCor Site 73
state: California
city: Los Angeles
country: United States
facility: CinCor Site 36
state: California
city: Lynwood
country: United States
facility: CinCor Site 34
state: California
city: San Dimas
country: United States
facility: CinCor Site 14
state: California
city: Santa Ana
country: United States
facility: CinCor Site 28
state: California
city: Spring Valley
country: United States
facility: CinCor Site 19
state: California
city: Tustin
country: United States
facility: CinCor Site 32
state: California
city: West Hills
country: United States
facility: CinCor Site 44
state: California
city: Whittier
country: United States
facility: CinCor Site 66
state: California
city: Stamford
country: United States
facility: CinCor Site 56
state: Connecticut
city: Clearwater
country: United States
facility: CinCor Site 30
state: Florida
city: Fort Myers
country: United States
facility: CinCor Site 13
state: Florida
city: Hialeah
country: United States
facility: CinCor Site 74
state: Florida
city: Homestead
country: United States
facility: CinCor Site 22
state: Florida
city: Jacksonville
country: United States
facility: CinCor Site 20
state: Florida
city: Jupiter
country: United States
facility: CinCor Site 1
state: Florida
city: Lake Worth
country: United States
facility: CinCor Site 84
state: Florida
city: Miami
country: United States
facility: CinCor Site 70
state: Florida
city: Miami
country: United States
facility: CinCor Site 89
state: Florida
city: Miami
country: United States
facility: CinCor Site 94
state: Florida
city: Port Orange
country: United States
facility: CinCor Site 5
state: Florida
city: Saint Petersburg
country: United States
facility: CinCor Site 9
state: Florida
city: Tampa
country: United States
facility: CinCor Site 23
state: Florida
city: Winter Haven
country: United States
facility: CinCor Site 88
state: Florida
city: Suwanee
country: United States
facility: CinCor Site 71
state: Georgia
city: Meridian
country: United States
facility: CinCor Site 11
state: Idaho
city: Addison
country: United States
facility: CinCor Site 15
state: Illinois
city: Arlington Heights
country: United States
facility: CinCor Site 81
state: Illinois
city: Chicago
country: United States
facility: CinCor Site 49
state: Illinois
city: Morton
country: United States
facility: CinCor Site 35
state: Illinois
city: Evansville
country: United States
facility: CinCor Site 58
state: Indiana
city: West Des Moines
country: United States
facility: CinCor Site 54
state: Iowa
city: Lexington
country: United States
facility: CinCor Site 29
state: Kentucky
city: Lexington
country: United States
facility: CinCor Site 24
state: Kentucky
city: New Orleans
country: United States
facility: CinCor Site 69
state: Louisiana
city: Shreveport
country: United States
facility: CinCor Site 64
state: Louisiana
city: Baltimore
country: United States
facility: CinCor Site 75
state: Maryland
city: Elkridge
country: United States
facility: CinCor Site 65
state: Maryland
city: Roseville
country: United States
facility: CinCor Site 52
state: Michigan
city: Troy
country: United States
facility: CinCor Site 21
state: Michigan
city: Hattiesburg
country: United States
facility: CinCor Site 92
state: Mississippi
city: Olive Branch
country: United States
facility: CinCor Site 50
state: Mississippi
city: Butte
country: United States
facility: CinCor Site 45
state: Montana
city: Las Vegas
country: United States
facility: CinCor Site 47
state: Nevada
city: Albuquerque
country: United States
facility: CinCor Site 31
state: New Mexico
city: Bronx
country: United States
facility: CinCor Site 4
state: New York
city: Johnson City
country: United States
facility: CinCor Site 55
state: New York
city: Cincinnati
country: United States
facility: CinCor Site 59
state: Ohio
city: Cincinnati
country: United States
facility: CinCor Site 6
state: Ohio
city: Cincinnati
country: United States
facility: CinCor Site 7
state: Ohio
city: Dayton
country: United States
facility: CinCor Site 86
state: Ohio
city: Beaver
country: United States
facility: CinCor Site 43
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: CinCor Site 39
state: South Carolina
city: Jackson
country: United States
facility: CinCor Site 97
state: Tennessee
city: Knoxville
country: United States
facility: CinCor Site 42
state: Tennessee
city: Austin
country: United States
facility: CinCor Site 27
state: Texas
city: Carrollton
country: United States
facility: CinCor Site 80
state: Texas
city: Dallas
country: United States
facility: CinCor Site 79
state: Texas
city: Friendswood
country: United States
facility: CinCor Site 87
state: Texas
city: Houston
country: United States
facility: CinCor Site 2
state: Texas
city: Houston
country: United States
facility: CinCor Site 72
state: Texas
city: Hurst
country: United States
facility: CinCor Site 46
state: Texas
city: Kerville
country: United States
facility: CinCor Site 93
state: Texas
city: McAllen
country: United States
facility: CinCor Site 37
state: Texas
city: Sugar Land
country: United States
facility: CinCor Site 85
state: Texas
city: Draper
country: United States
facility: CinCor Site 48
state: Utah
city: Salt Lake City
country: United States
facility: CinCor Site 3
state: Utah
city: Alexandria
country: United States
facility: CinCor Site 77
state: Virginia
city: Burke
country: United States
facility: CinCor Site 8
state: Virginia
city: Manassas
country: United States
facility: CinCor Site 33
state: Virginia
city: Norfolk
country: United States
facility: CinCor Site 76
state: Virginia
city: Olympia
country: United States
facility: CinCor Site 41
state: Washington
city: Kenosha
country: United States
facility: CinCor Site 51
state: Wisconsin
Study officials:
References:
citation: Freeman MW, Halvorsen YD, Marshall W, Pater M, Isaacsohn J, Pearce C, Murphy B, Alp N, Srivastava A, Bhatt DL, Brown MJ; BrigHTN Investigators. Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension. N Engl J Med. 2023 Feb 2;388(5):395-405. doi: 10.1056/NEJMoa2213169. Epub 2022 Nov 7.