Trial Outcomes & Findings for A Study of CIN-107 in Patients With Uncontrolled Hypertension (NCT NCT05137002)
NCT ID: NCT05137002
Last Updated: 2023-08-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
249 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-08-01
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
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)
|
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
|
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).
|
|---|---|---|---|---|---|
|
Part I (8 Weeks)
STARTED
|
64
|
63
|
62
|
60
|
0
|
|
Part I (8 Weeks)
COMPLETED
|
60
|
55
|
58
|
54
|
0
|
|
Part I (8 Weeks)
NOT COMPLETED
|
4
|
8
|
4
|
6
|
0
|
|
Part II (4 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
213
|
|
Part II (4 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
201
|
|
Part II (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of CIN-107 in Patients With Uncontrolled Hypertension
Baseline characteristics by cohort
| Measure |
Placebo
n=64 Participants
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
|
CIN-107 0.5 mg
n=63 Participants
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
|
CIN-107 1 mg
n=62 Participants
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
|
CIN-107 2 mg
n=60 Participants
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
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 10.85 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 11.88 • n=4 Participants
|
60.2 years
STANDARD_DEVIATION 10.96 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
63 participants
n=7 Participants
|
62 participants
n=5 Participants
|
60 participants
n=4 Participants
|
249 participants
n=21 Participants
|
|
Seated SBP
|
147.9 mmHg
STANDARD_DEVIATION 9.33 • n=5 Participants
|
146.3 mmHg
STANDARD_DEVIATION 8.60 • n=7 Participants
|
147.0 mmHg
STANDARD_DEVIATION 9.07 • n=5 Participants
|
146.3 mmHg
STANDARD_DEVIATION 7.83 • n=4 Participants
|
146.9 mmHg
STANDARD_DEVIATION 8.71 • n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Placebo
n=61 Participants
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
|
CIN-107 0.5 mg
n=57 Participants
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
|
CIN-107 1 mg
n=58 Participants
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
|
CIN-107 2 mg
n=55 Participants
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
|
|---|---|---|---|---|
|
Change From Baseline in Mean Seated Systolic BP (SBP)
|
-16.6 mmHg
Standard Error 1.58
|
-17.0 mmHg
Standard Error 1.63
|
-16.0 mmHg
Standard Error 1.62
|
-19.8 mmHg
Standard Error 1.67
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Outcome measures
| Measure |
Placebo
n=61 Participants
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
|
CIN-107 0.5 mg
n=57 Participants
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
|
CIN-107 1 mg
n=58 Participants
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
|
CIN-107 2 mg
n=55 Participants
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
|
|---|---|---|---|---|
|
Change From Baseline in Mean Seated Diastolic BP (DBP)
|
-5.9 mmHg
Standard Error 1.17
|
-5.8 mmHg
Standard Error 1.20
|
-5.0 mmHg
Standard Error 1.19
|
-5.4 mmHg
Standard Error 1.23
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
Outcome measures
| Measure |
Placebo
n=59 Participants
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
|
CIN-107 0.5 mg
n=54 Participants
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
|
CIN-107 1 mg
n=55 Participants
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
|
CIN-107 2 mg
n=54 Participants
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
|
|---|---|---|---|---|
|
Change From Baseline in 24-hour Urine Aldosterone
|
-19.90 ng/g
Standard Error 29.183
|
-114.16 ng/g
Standard Error 31.305
|
-140.45 ng/g
Standard Error 29.999
|
-121.64 ng/g
Standard Error 30.760
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
Outcome measures
| Measure |
Placebo
n=57 Participants
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
|
CIN-107 0.5 mg
n=57 Participants
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
|
CIN-107 1 mg
n=52 Participants
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
|
CIN-107 2 mg
n=52 Participants
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
|
|---|---|---|---|---|
|
Change From Baseline in 24-hour Serum Aldosterone
|
-0.70 ng/dL
Standard Error 0.490
|
-2.76 ng/dL
Standard Error 0.493
|
-2.95 ng/dL
Standard Error 0.508
|
-2.92 ng/dL
Standard Error 0.515
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
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)
Outcome measures
| Measure |
Placebo
n=64 Participants
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
|
CIN-107 0.5 mg
n=63 Participants
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
|
CIN-107 1 mg
n=62 Participants
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
|
CIN-107 2 mg
n=60 Participants
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
|
|---|---|---|---|---|
|
Percentage of Patients Achieving a Mean Seated SBP <130 mmHg
|
36 Participants
|
36 Participants
|
33 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Outcome measures
| Measure |
Placebo
n=5 Participants
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
|
CIN-107 0.5 mg
n=4 Participants
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
|
CIN-107 1 mg
n=10 Participants
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
|
CIN-107 2 mg
n=4 Participants
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
|
|---|---|---|---|---|
|
Change From Baseline in 24-hour Urine Renin
|
-20.08 ng/day
Standard Error 16.584
|
-6.54 ng/day
Standard Error 15.739
|
-5.74 ng/day
Standard Error 10.703
|
4.11 ng/day
Standard Error 17.930
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Outcome measures
| Measure |
Placebo
n=5 Participants
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
|
CIN-107 0.5 mg
n=2 Participants
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
|
CIN-107 1 mg
n=10 Participants
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
|
CIN-107 2 mg
n=4 Participants
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
|
|---|---|---|---|---|
|
Change From Baseline in 24-hour Serum Renin
|
92.902 ng/L
Standard Error 144.3969
|
63.565 ng/L
Standard Error 195.0495
|
88.041 ng/L
Standard Error 91.2996
|
-140.961 ng/L
Standard Error 151.5431
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
CIN-107 0.5 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CIN-107 1 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CIN-107 2 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part II - CIN-107 2 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=64 participants at risk
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)
|
CIN-107 0.5 mg
n=63 participants at risk
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)
|
CIN-107 1 mg
n=62 participants at risk
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)
|
CIN-107 2 mg
n=60 participants at risk
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
|
Part II - CIN-107 2 mg
n=213 participants at risk
CIN-107: (2mg) CIN-107 tablets by mouth once daily and discontinue their background anti-hypertensive agent(s) for 4 weeks (Part II).
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/64 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/63 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/62 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/60 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.47%
1/213 • Number of events 1 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
|
Nervous system disorders
Dizziness
|
0.00%
0/64 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/63 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/62 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/60 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.47%
1/213 • Number of events 1 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/64 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/63 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/62 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/60 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.47%
1/213 • Number of events 1 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/64 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/63 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/62 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/60 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.47%
1/213 • Number of events 1 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/64 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/63 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
1.6%
1/62 • Number of events 1 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/60 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/213 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/64 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/63 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/62 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
1.7%
1/60 • Number of events 1 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/213 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
Other adverse events
| Measure |
Placebo
n=64 participants at risk
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)
|
CIN-107 0.5 mg
n=63 participants at risk
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)
|
CIN-107 1 mg
n=62 participants at risk
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)
|
CIN-107 2 mg
n=60 participants at risk
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
|
Part II - CIN-107 2 mg
n=213 participants at risk
CIN-107: (2mg) CIN-107 tablets by mouth once daily and discontinue their background anti-hypertensive agent(s) for 4 weeks (Part II).
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.7%
3/64 • Number of events 3 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/63 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
8.1%
5/62 • Number of events 5 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
5.0%
3/60 • Number of events 3 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
2.8%
6/213 • Number of events 6 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
|
Investigations
SARS-CoV-2 test positive
|
3.1%
2/64 • Number of events 2 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
6.3%
4/63 • Number of events 4 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
1.6%
1/62 • Number of events 1 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/60 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/213 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/64 • Number of events 1 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
6.3%
4/63 • Number of events 4 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/62 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/60 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
0.00%
0/213 • Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER