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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIN-107 | Drug | CIN-107 tablets by mouth once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Seated Systolic BP (SBP) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Seated Diastolic BP (DBP) | 12 weeks | |
| The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CinCor Site 16 | Birmingham | Alabama | 35209 | United States | ||
| CinCor Site 38 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36342143 | Background | 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. |
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There was a 2-week Single Blind Run-In (SB-RI) period with administration of placebo before inclusion in the double-blind, randomized part of the study. 360 patients entered SB-RI and 85 patients withdrew early from SB-RI. 275 patients were randomized to 1 of the 4 treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | CIN-107 Dose 1 (0.5mg) | CIN-107: CIN-107 tablets by mouth once daily |
| FG001 | CIN-107 Dose 2 (1mg) | CIN-107: CIN-107 tablets by mouth once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2021 | Jun 7, 2023 |
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| Placebo | Drug | placebo tablets by mouth once daily |
|
| Birmingham |
| Alabama |
| 35294-0007 |
| United States |
| CinCor Site 61 | Saraland | Alabama | 36571 | United States |
| CinCor Site 90 | Tucson | Arizona | 85715 | United States |
| CinCor Site 82 | Anaheim | California | 92805 | United States |
| CinCor Site 91 | Granada Hills | California | 91344 | United States |
| CinCor Site 25 | Lincoln | California | 95821 | United States |
| CinCor Site 73 | Los Angeles | California | 90048 | United States |
| CinCor Site 36 | Los Angeles | California | 90057 | United States |
| CinCor Site 34 | Lynwood | California | 90262 | United States |
| CinCor Site 14 | San Dimas | California | 91773 | United States |
| CinCor Site 28 | Santa Ana | California | 92705 | United States |
| CinCor Site 19 | Spring Valley | California | 91978 | United States |
| CinCor Site 32 | Tustin | California | 92780 | United States |
| CinCor Site 44 | West Hills | California | 91405 | United States |
| CinCor Site 66 | Whittier | California | 90211 | United States |
| CinCor Site 56 | Stamford | Connecticut | 06905 | United States |
| CinCor Site 30 | Clearwater | Florida | 33765 | United States |
| CinCor Site 13 | Fort Myers | Florida | 33912 | United States |
| CinCor Site 74 | Hialeah | Florida | 33013 | United States |
| CinCor Site 22 | Homestead | Florida | 33166 | United States |
| CinCor Site 20 | Jacksonville | Florida | 32216 | United States |
| CinCor Site 1 | Jupiter | Florida | 33458 | United States |
| CinCor Site 84 | Lake Worth | Florida | 33467 | United States |
| CinCor Site 70 | Miami | Florida | 33012 | United States |
| CinCor Site 89 | Miami | Florida | 33032 | United States |
| CinCor Site 94 | Miami | Florida | 33033 | United States |
| CinCor Site 5 | Port Orange | Florida | 32127 | United States |
| CinCor Site 9 | St. Petersburg | Florida | 33709 | United States |
| CinCor Site 23 | Tampa | Florida | 33606 | United States |
| CinCor Site 88 | Winter Haven | Florida | 33880 | United States |
| CinCor Site 71 | Suwanee | Georgia | 30024 | United States |
| CinCor Site 11 | Meridian | Idaho | 83642 | United States |
| CinCor Site 15 | Addison | Illinois | 60101 | United States |
| CinCor Site 81 | Arlington Heights | Illinois | 60005 | United States |
| CinCor Site 49 | Chicago | Illinois | 60607 | United States |
| CinCor Site 35 | Morton | Illinois | 61550 | United States |
| CinCor Site 58 | Evansville | Indiana | 47714 | United States |
| CinCor Site 54 | West Des Moines | Iowa | 50266 | United States |
| CinCor Site 29 | Lexington | Kentucky | 40503 | United States |
| CinCor Site 24 | Lexington | Kentucky | 40509 | United States |
| CinCor Site 69 | New Orleans | Louisiana | 70119 | United States |
| CinCor Site 64 | Shreveport | Louisiana | 71101 | United States |
| CinCor Site 75 | Baltimore | Maryland | 21201 | United States |
| CinCor Site 65 | Elkridge | Maryland | 21075 | United States |
| CinCor Site 52 | Roseville | Michigan | 48066 | United States |
| CinCor Site 21 | Troy | Michigan | 48085 | United States |
| CinCor Site 92 | Hattiesburg | Mississippi | 39401 | United States |
| CinCor Site 50 | Olive Branch | Mississippi | 38654 | United States |
| CinCor Site 45 | Butte | Montana | 59701 | United States |
| CinCor Site 47 | Las Vegas | Nevada | 89119 | United States |
| CinCor Site 31 | Albuquerque | New Mexico | 87102 | United States |
| CinCor Site 55 | Johnson City | New York | 13901 | United States |
| CinCor Site 4 | The Bronx | New York | 10455 | United States |
| CinCor Site 59 | Cincinnati | Ohio | 45212 | United States |
| CinCor Site 6 | Cincinnati | Ohio | 45246 | United States |
| CinCor Site 7 | Cincinnati | Ohio | 45246 | United States |
| CinCor Site 86 | Dayton | Ohio | 45439 | United States |
| CinCor Site 43 | Beaver | Pennsylvania | 15066 | United States |
| CinCor Site 39 | Myrtle Beach | South Carolina | 29588 | United States |
| CinCor Site 97 | Jackson | Tennessee | 38305 | United States |
| CinCor Site 42 | Knoxville | Tennessee | 37920 | United States |
| CinCor Site 27 | Austin | Texas | 78705 | United States |
| CinCor Site 80 | Carrollton | Texas | 75006 | United States |
| CinCor Site 79 | Dallas | Texas | 75234 | United States |
| CinCor Site 87 | Friendswood | Texas | 77089 | United States |
| CinCor Site 2 | Houston | Texas | 77040 | United States |
| CinCor Site 72 | Houston | Texas | 77054 | United States |
| CinCor Site 46 | Hurst | Texas | 76054 | United States |
| CinCor Site 93 | Kerville | Texas | 78028 | United States |
| CinCor Site 37 | McAllen | Texas | 78503 | United States |
| CinCor Site 85 | Sugar Land | Texas | 77479 | United States |
| CinCor Site 48 | Draper | Utah | 84020 | United States |
| CinCor Site 3 | Salt Lake City | Utah | 84107 | United States |
| CinCor Site 77 | Alexandria | Virginia | 22304 | United States |
| CinCor Site 8 | Burke | Virginia | 22015 | United States |
| CinCor Site 33 | Manassas | Virginia | 20110 | United States |
| CinCor Site 76 | Norfolk | Virginia | 23510 | United States |
| CinCor Site 41 | Olympia | Washington | 98502 | United States |
| CinCor Site 51 | Kenosha | Wisconsin | 60031 | United States |
| FG002 | CIN-107 Dose 3 (2mg) | CIN-107: CIN-107 tablets by mouth once daily |
| FG003 | Placebo | Placebo: placebo tablets by mouth once daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CIN-107 Dose 1 (0.5mg) | CIN-107: CIN-107 tablets by mouth once daily |
| BG001 | CIN-107 Dose 2 (1mg) | CIN-107: CIN-107 tablets by mouth once daily |
| BG002 | CIN-107 Dose 3 (2mg) | CIN-107: CIN-107 tablets by mouth once daily |
| BG003 | Placebo | Placebo: placebo tablets by mouth once daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Seated SBP | Mean | Standard Deviation | mmHg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Seated Systolic BP (SBP) | Only patients with non-missing baseline and the specified visit were included. | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
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| Secondary | Change From Baseline in Mean Seated Diastolic BP (DBP) | Only patients with non-missing baseline and the specified visit were included. | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg | The modified ITT (mITT) Population included all patients in the ITT Population who received at least 1 dose of any study drug and had a baseline value for the SBP assessment. Any efficacy measurement obtained after a patient received a restricted BP altering therapy, outside of the current study design, was removed from the mITT analysis. | Posted | Count of Participants | Participants | 12 weeks |
|
From the time of informed consent to the end of the Follow-up Period, up to 24 weeks.
One patient who was randomized to the 1 mg CIN-107 treatment group withdrew from the study prior to treatment with the study drug due to the physician's decision.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population 0.5mg | The Safety Population included all patients who received at least 1 dose of any randomized study drug. | 0 | 69 | 0 | 69 | 6 | 69 |
| EG001 | Safety Population 1mg | The Safety Population included all patients who received at least 1 dose of any randomized study drug. | 0 | 69 | 2 | 69 | 16 | 69 |
| EG002 | Safety Population 2mg | The Safety Population included all patients who received at least 1 dose of any randomized study drug. | 0 | 67 | 6 | 67 | 8 | 67 |
| EG003 | Safety Population Placebo | The Safety Population included all patients who received at least 1 dose of any randomized study drug. | 0 | 69 | 2 | 69 | 10 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo for up to 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuan-Di Halvorsen | CinCor Pharma | 617-675-8126 | yhalvorsen@cincor.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2022 | Jun 7, 2023 | SAP_001.pdf |
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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The mITT Population included all patients in the ITT Population who received at least 1 dose of any study drug and had a baseline value for the SBP assessment. |
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