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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIN-107 0.5 mg | Experimental | 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 |
|
| CIN-107 1 mg | Experimental | 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 |
|
| CIN-107 2 mg | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| 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) | 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). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Seated Diastolic BP (DBP) | The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) | 8 weeks |
| Change From Baseline in 24-hour Urine Aldosterone |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CinCor Site 27 | Saraland | Alabama | 36571 | United States | ||
| CinCor Site 35 |
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A Run-In Period up to 4 weeks before randomization, to confirm the patient's adherence to their background antihypertensive medication(s) and placebo was done. A total of 631 patients were screened for the study, of which 382 (60.5%) patients failed the screening. Two hundred forty-nine patients were randomized to 1 of the 4 treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo tablets by mouth once daily. IMP is taken as add-on while remaining on background anti-hypersensitive regimen for 8 weeks (Part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks (Part II) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part I (8 Weeks) |
|
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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 | Feb 25, 2022 | Jun 30, 2023 |
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| Placebo | Drug | Placebo tablets by mouth once daily |
|
The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
| 8 weeks |
| Change From Baseline in 24-hour Serum Aldosterone | The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1) | 8 weeks |
| Percentage of Patients Achieving a Mean Seated SBP <130 mmHg | 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) | 8 weeks |
| Change From Baseline in 24-hour Urine Renin | The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) | 8 weeks |
| Change From Baseline in 24-hour Serum Renin | The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) | 8 weeks |
| Tucson |
| Arizona |
| 85712 |
| United States |
| CinCor Site 69 | Encinitas | California | 92024 | United States |
| CinCor Site 6 | Lincoln | California | 95648 | United States |
| CinCor Site 20 | Los Angeles | California | 90057 | United States |
| CinCor Site 70 | Lynwood | California | 90262 | United States |
| CinCor Site 36 | Northridge | California | 91324 | United States |
| CinCor Site 29 | Oceanside | California | 92049 | United States |
| CinCor Site 46 | Panorama City | California | 91402 | United States |
| CinCor Site 47 | San Dimas | California | 91773 | United States |
| CinCor Site 49 | Santa Ana | California | 92705 | United States |
| CinCor Site 52 | West Hills | California | 91307 | United States |
| CinCor Site 57 | Denver | Colorado | 80209 | United States |
| CinCor Site 31 | Waterbury | Connecticut | 06708 | United States |
| CinCor Site 18 | Clearwater | Florida | 33765 | United States |
| CinCor Site 41 | Cooper City | Florida | 33024 | United States |
| CinCor Site 28 | Homestead | Florida | 33166 | United States |
| CinCor Site 9 | Jupiter | Florida | 33458 | United States |
| CinCor Site 1 | Lake Worth | Florida | 33460 | United States |
| CinCor Site 12 | Miami | Florida | 33032 | United States |
| CinCor Site 54 | Miami | Florida | 33106 | United States |
| CinCor Site 13 | Miami | Florida | 33155 | United States |
| CinCor Site 17 | Miami | Florida | 33183 | United States |
| CinCor Site 16 | Tampa | Florida | 33606 | United States |
| CinCor Site 34 | Winter Haven | Florida | 33880 | United States |
| CinCor Site 14 | Buford | Georgia | 30519 | United States |
| CinCor Site 33 | Addison | Illinois | 60101 | United States |
| CinCor Site 40 | Chicago | Illinois | 60607 | United States |
| CinCor Site 42 | Gurnee | Illinois | 60031 | United States |
| CinCor Site 50 | Morton | Illinois | 61550 | United States |
| CinCor Site 72 | Brownsburg | Indiana | 46112 | United States |
| CinCor Site 63 | West Des Moines | Iowa | 50266 | United States |
| CinCor Site 7 | Lexington | Kentucky | 40503 | United States |
| CinCor Site 21 | Louisville | Kentucky | 40213 | United States |
| CinCor Site 30 | Marrero | Louisiana | 70072 | United States |
| CinCor Site 59 | Metairie | Louisiana | 70004 | United States |
| CinCor Site 19 | New Orleans | Louisiana | 70112 | United States |
| CinCor Site 25 | Shreveport | Louisiana | 71106 | United States |
| CinCor Site 38 | Elkridge | Maryland | 21043 | United States |
| CinCor Site 38 | Elkridge | Maryland | 21075 | United States |
| CinCor Site 22 | Troy | Michigan | 48085 | United States |
| CinCor Site 64 | Olive Branch | Mississippi | 38654 | United States |
| CinCor Site 11 | Brooklyn | New York | 11201 | United States |
| CinCor Site 65 | Staten Island | New York | 10305 | United States |
| CinCor Site 15 | Cincinnati | Ohio | 45221 | United States |
| CinCor Site 24 | Columbus | Ohio | 43213 | United States |
| CinCor Site 4 | Dayton | Ohio | 45377 | United States |
| CinCor Site 43 | Oklahoma City | Oklahoma | 73119 | United States |
| CinCor Site 60 | Chattanooga | Tennessee | 37401 | United States |
| CinCor Site 48 | Austin | Texas | 78705 | United States |
| CinCor Site 32 | Carrollton | Texas | 75006 | United States |
| CinCor Site 68 | Dallas | Texas | 75234 | United States |
| CinCor Site 61 | Georgetown | Texas | 78613 | United States |
| CinCor Site 55 | Houston | Texas | 77036 | United States |
| CinCor Site 3 | Houston | Texas | 77040 | United States |
| CinCor Site 58 | Katy | Texas | 77450 | United States |
| CinCor Site 62 | Lampasas | Texas | 76550 | United States |
| CinCor Site 26 | McAllen | Texas | 78501 | United States |
| CinCor Site 53 | San Antonio | Texas | 78209 | United States |
| CinCor Site 10 | Sugar Land | Texas | 77479 | United States |
| CinCor Site 45 | Salt Lake City | Utah | 84102 | United States |
| CinCor Site 2 | Manassas | Virginia | 20108 | United States |
| CinCor Site 5 | Norfolk | Virginia | 23510 | United States |
| CIN-107 0.5 mg |
CIN-107: (0.5mg) CIN-107 tablets by mouth once daily. IMP is taken as add-on while remaining on background anti-hypersensitive regimen for 8 weeks (Part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (Part II) |
| FG002 | CIN-107 1 mg | CIN-107: (1mg) CIN-107 tablets by mouth once daily. IMP is taken as add-on while remaining on background anti-hypersensitive regimen for 8 weeks (Part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (Part II) |
| FG003 | CIN-107 2 mg | CIN-107: (2mg) CIN-107 tablets by mouth once daily. IMP is taken as add-on while remaining on background anti-hypersensitive regimen for 8 weeks (Part I). After 8 weeks, patients may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (Part II) or withdraw study participation depending on BP control |
| FG004 | Part II - CIN-107 2mg | CIN-107: (2mg) CIN-107 tablets by mouth once daily. After 8 weeks, patients may switch to or remain on 2mg CIN-107 and discontinue their background antihypertensive agent(s) for 4 weeks (Part II). |
| COMPLETED |
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| NOT COMPLETED |
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| Part II (4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Placebo: Placebo tablets by mouth once daily |
| BG001 | 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 CIN-107: CIN-107 tablets by mouth once daily |
| BG002 | 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 CIN-107: CIN-107 tablets by mouth once daily |
| BG003 | 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 CIN-107: CIN-107 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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) | 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). | mITT Population - Four subjects (1, 2, 1 subjects from Placebo, 0.5mg CIN 107, and 2mg CIN 107, respectively) discontinued Part 1 early, but had their early termination (ET) visits within Week 8/Visit 6 analysis visit window. | Posted | Least Squares Mean | Standard Error | mmHg | 8 weeks |
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| Secondary | Change From Baseline in Mean Seated Diastolic BP (DBP) | The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) | mITT Population - Four subjects (1, 2, 1 subjects from Placebo, 0.5mg CIN 107, and 2mg CIN 107, respectively) discontinued Part 1 early, but had their early termination (ET) visits within Week 8/Visit 6 analysis visit window. | Posted | Least Squares Mean | Standard Error | mmHg | 8 weeks |
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| Secondary | Change From Baseline in 24-hour Urine Aldosterone | The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1) | mITT population - Two subjects discontinued Part 1 early, but had their ET measures taken within Week8/Visit 6 analysis visit window: 1 from Placebo and 1 from 0.5mg. In addition, 7 subjects completed Part 1 but either did not have baseline measure or did not have Week 8/Visit 6 measure: 2, 2, 3 subjects from Placebo, 0.5mg CIN 107, and 1mg CIN 107, respectively. | Posted | Least Squares Mean | Standard Error | ng/g | 8 weeks |
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| Secondary | Change From Baseline in 24-hour Serum Aldosterone | The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1) | mITT population - Four subjects discontinued Part 1 early, but had their ET measures taken within Week8/Visit 6 analysis visit window: 1, 2, 1 subjects from Placebo, 0.5mg CIN 107, and 2mg CIN 107, respectively. In addition, 13 subjects completed Part 1 but either did not have baseline measure or did not have Week 8/Visit 6 measure: 4, 6, 3 subjects from Placebo, 1mg CIN 107, and 2mg CIN 107, respectively. | Posted | Least Squares Mean | Standard Error | ng/dL | 8 weeks |
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| Secondary | Percentage of Patients Achieving a Mean Seated SBP <130 mmHg | 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) | mITT population - Patients without a Week 8/Visit 6 systolic blood pressure measure were considered non-responders. So, if a subject was in the mITT Population but discontinued the study early or if SBP measure was unavailable at Week 8, then they were considered non responders and still contributed to the total number of participants used in analyses. | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Change From Baseline in 24-hour Urine Renin | The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) | mITT population - The 24 hour urine renin pharmacodynamic analyte was added in later, with protocol v3.0. Only subjects who had this measured at baseline are included in overall number of participants analyzed. | Posted | Least Squares Mean | Standard Error | ng/day | 8 weeks |
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| Secondary | Change From Baseline in 24-hour Serum Renin | The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1) | mITT population - The 24 hour serum renin pharmacodynamic analyte was added in later, with protocol v3.0. Only subjects who had this measured at baseline are included in overall number of participants analyzed. | Posted | Least Squares Mean | Standard Error | ng/L | 8 weeks |
|
Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
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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 | Placebo | CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) | 0 | 64 | 0 | 64 | 5 | 64 |
| EG001 | CIN-107 0.5 mg | CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) | 0 | 63 | 0 | 63 | 8 | 63 |
| EG002 | CIN-107 1 mg | CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) | 0 | 62 | 1 | 62 | 6 | 62 |
| EG003 | CIN-107 2 mg | CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I). After 8 weeks, patients may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) or withdraw study participation depending on BP control | 1 | 60 | 1 | 60 | 3 | 60 |
| EG004 | Part II - CIN-107 2 mg | CIN-107: (2mg) CIN-107 tablets by mouth once daily and discontinue their background anti-hypertensive agent(s) for 4 weeks (Part II). | 0 | 213 | 3 | 213 | 6 | 213 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Hypertensive urgency | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | 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 | Oct 7, 2022 | Jun 30, 2023 | SAP_001.pdf |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| 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 |
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| Unknown or Not Reported |
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| OG003 | 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 CIN-107: CIN-107 tablets by mouth once daily |
|
|
| OG003 | 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 CIN-107: CIN-107 tablets by mouth once daily |
|
|
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
CIN-107: CIN-107 tablets by mouth once daily
| OG003 | 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 CIN-107: CIN-107 tablets by mouth once daily |
|
|
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
CIN-107: CIN-107 tablets by mouth once daily
| OG003 | 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 CIN-107: CIN-107 tablets by mouth once daily |
|
|
| OG003 | 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 CIN-107: CIN-107 tablets by mouth once daily |
|
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| OG003 | 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 CIN-107: CIN-107 tablets by mouth once daily |
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