Resistant HypertensionPhase 2BrigHTNNCT04519658

A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)

A Phase 2 study testing CIN-107 in people with Resistant Hypertension, run by CinCor Pharma, Inc. at 80 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Resistant Hypertension
What is being tested?: CIN-107
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 275 participants
Where: 80 sitesUnited States
Study dates: 12 Oct 2020to 14 Jun 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 19Show fewer

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.

Trial locations and contacts

80 sites in 1 country.

City, postcode or hospital

80 sites in 1 country

United States80 sites

CinCor Site 15
Addison, Illinois, 60101
CinCor Site 31
Albuquerque, New Mexico, 87102
CinCor Site 77
Alexandria, Virginia, 22304
CinCor Site 82
Anaheim, California, 92805
CinCor Site 81
Arlington Heights, Illinois, 60005
CinCor Site 27
Austin, Texas, 78705
CinCor Site 75
Baltimore, Maryland, 21201
CinCor Site 43
Beaver, Pennsylvania, 15066
CinCor Site 16
Birmingham, Alabama, 35209
CinCor Site 38
Birmingham, Alabama, 35294-0007
CinCor Site 8
Burke, Virginia, 22015
CinCor Site 45
Butte, Montana, 59701
CinCor Site 80
Carrollton, Texas, 75006
CinCor Site 49
Chicago, Illinois, 60607
CinCor Site 59
Cincinnati, Ohio, 45212
CinCor Site 6
Cincinnati, Ohio, 45246
CinCor Site 7
Cincinnati, Ohio, 45246
CinCor Site 30
Clearwater, Florida, 33765
CinCor Site 79
Dallas, Texas, 75234
CinCor Site 86
Dayton, Ohio, 45439
CinCor Site 48
Draper, Utah, 84020
CinCor Site 65
Elkridge, Maryland, 21075
CinCor Site 58
Evansville, Indiana, 47714
CinCor Site 13
Fort Myers, Florida, 33912
CinCor Site 87
Friendswood, Texas, 77089
CinCor Site 91
Granada Hills, California, 91344
CinCor Site 92
Hattiesburg, Mississippi, 39401
CinCor Site 74
Hialeah, Florida, 33013
CinCor Site 22
Homestead, Florida, 33166
CinCor Site 2
Houston, Texas, 77040
CinCor Site 72
Houston, Texas, 77054
CinCor Site 46
Hurst, Texas, 76054
CinCor Site 97
Jackson, Tennessee, 38305
CinCor Site 20
Jacksonville, Florida, 32216
CinCor Site 55
Johnson City, New York, 13901
CinCor Site 1
Jupiter, Florida, 33458
CinCor Site 51
Kenosha, Wisconsin, 60031
CinCor Site 93
Kerville, Texas, 78028
CinCor Site 42
Knoxville, Tennessee, 37920
CinCor Site 84
Lake Worth, Florida, 33467
CinCor Site 47
Las Vegas, Nevada, 89119
CinCor Site 29
Lexington, Kentucky, 40503
CinCor Site 24
Lexington, Kentucky, 40509
CinCor Site 25
Lincoln, California, 95821
CinCor Site 73
Los Angeles, California, 90048
CinCor Site 36
Los Angeles, California, 90057
CinCor Site 34
Lynwood, California, 90262
CinCor Site 33
Manassas, Virginia, 20110
CinCor Site 37
McAllen, Texas, 78503
CinCor Site 11
Meridian, Idaho, 83642
CinCor Site 70
Miami, Florida, 33012
CinCor Site 89
Miami, Florida, 33032
CinCor Site 94
Miami, Florida, 33033
CinCor Site 35
Morton, Illinois, 61550
CinCor Site 39
Myrtle Beach, South Carolina, 29588
CinCor Site 69
New Orleans, Louisiana, 70119
CinCor Site 76
Norfolk, Virginia, 23510
CinCor Site 50
Olive Branch, Mississippi, 38654
CinCor Site 41
Olympia, Washington, 98502
CinCor Site 5
Port Orange, Florida, 32127
CinCor Site 52
Roseville, Michigan, 48066
CinCor Site 3
Salt Lake City, Utah, 84107
CinCor Site 14
San Dimas, California, 91773
CinCor Site 28
Santa Ana, California, 92705
CinCor Site 61
Saraland, Alabama, 36571
CinCor Site 64
Shreveport, Louisiana, 71101
CinCor Site 19
Spring Valley, California, 91978
CinCor Site 9
St. Petersburg, Florida, 33709
CinCor Site 56
Stamford, Connecticut, 06905
CinCor Site 85
Sugar Land, Texas, 77479
CinCor Site 71
Suwanee, Georgia, 30024
CinCor Site 23
Tampa, Florida, 33606
CinCor Site 4
The Bronx, New York, 10455
CinCor Site 21
Troy, Michigan, 48085
CinCor Site 90
Tucson, Arizona, 85715
CinCor Site 32
Tustin, California, 92780
CinCor Site 54
West Des Moines, Iowa, 50266
CinCor Site 44
West Hills, California, 91405
CinCor Site 66
Whittier, California, 90211
CinCor Site 88
Winter Haven, Florida, 33880

Other trials in United States

About this study

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)

Conditions: Resistant Hypertension
Being tested: CIN-107, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CIN-107Drug
Also called baxdrostat
CIN-107 tablets by mouth once daily
PlaceboDrug
placebo tablets by mouth once daily

Study groups in NCT04519658
Study group	Role	What they receive
CIN-107 0.5mg	Experimental	Subjects received CIN-107 0.5 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study. Receives: Drug: CIN-107
CIN-107 1mg	Experimental	Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study. Receives: Drug: CIN-107
CIN-107 2mg	Experimental	Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study. Receives: Drug: CIN-107
Placebo	Placebo comparator	Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Seated Systolic BP (SBP)
Measured: 12 weeks

Secondary outcomes (2)

Change From Baseline in Mean Seated Diastolic BP (DBP)
Measured: 12 weeks
The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 202014 Jun 2022

First posted20 Aug 2020
Study start12 Oct 2020
Primary completion14 Jun 2022
Study completion14 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Resistant HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04519658
Sponsor's protocol ID: CIN-107-121
Acronym: BrigHTN
Status last verified: Jul 2023
First submitted: 17 Aug 2020
Last updated: 24 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 36342143

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
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Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
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Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
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All Resistant Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04519658
Acronym / sponsor ID: BrigHTN / CIN-107-121
Conditions: Resistant Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 275 participants (actual)
Lead sponsor: CinCor Pharma, Inc.Industry (pharma, biotech, devices)
Study start: 12 Oct 2020 (actual)
Primary completion: 14 Jun 2022 (actual)
Study completion: 14 Jun 2022 (actual)
First posted: 20 Aug 2020 (actual)
Results: Posted 28 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
CIN-107 0.5mg	Experimental	Drug: CIN-107Subjects received CIN-107 0.5 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
CIN-107 1mg	Experimental	Drug: CIN-107Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
CIN-107 2mg	Experimental	Drug: CIN-107Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Placebo	Placebo comparator	Drug: PlaceboSubjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (19 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CIN-107Also: baxdrostatCIN-107 tablets by mouth once daily	Drug	CIN-107 0.5mg, CIN-107 1mg, CIN-107 2mg
Placeboplacebo tablets by mouth once daily	Drug	Placebo

Primary outcome

Change From Baseline in Mean Seated Systolic BP (SBP)
Time frame: 12 weeks

2 secondary outcomes

Change From Baseline in Mean Seated Diastolic BP (DBP)
Time frame: 12 weeks
The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg
Time frame: 12 weeks

Results and safety

Results posted to the registry on 28 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CIN-107 Dose 1 (0.5mg)	69	65
CIN-107 Dose 2 (1mg)	70	60
CIN-107 Dose 3 (2mg)	67	56
Placebo	69	67

Primary outcome: Change From Baseline in Mean Seated Systolic BP (SBP)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	mITT Population 0.5mg n = 65	mITT Population 1mg n = 60	mITT Population 2mg n = 54	mITT Population Placebo n = 67
Value	-12.4 (15.63)	-17.3 (18.10)	-19.2 (15.84)	-9.8 (13.71)

Population analysed: Only patients with non-missing baseline and the specified visit were included.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of informed consent to the end of the Follow-up Period, up to 24 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population 0.5mg	0 of 69 (0%)	6 of 69 (8.7%)	0 of 69
Safety Population 1mg	2 of 69 (2.9%)	16 of 69 (23.2%)	0 of 69
Safety Population 2mg	6 of 67 (9%)	8 of 67 (11.9%)	0 of 67
Safety Population Placebo	2 of 69 (2.9%)	10 of 69 (14.5%)	0 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36342143Freeman 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.

Related trials for Resistant Hypertension

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

80 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CIN-107 in people with Resistant Hypertension, run by CinCor Pharma, Inc. at 80 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Seated Systolic BP (SBP) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04519658, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.