Trial Outcomes & Findings for A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN) (NCT NCT04519658)
NCT ID: NCT04519658
Last Updated: 2023-07-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
275 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-24
Participant Flow
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.
Participant milestones
| Measure |
CIN-107 Dose 1 (0.5mg)
CIN-107: CIN-107 tablets by mouth once daily
|
CIN-107 Dose 2 (1mg)
CIN-107: CIN-107 tablets by mouth once daily
|
CIN-107 Dose 3 (2mg)
CIN-107: CIN-107 tablets by mouth once daily
|
Placebo
Placebo: placebo tablets by mouth once daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
67
|
69
|
|
Overall Study
COMPLETED
|
65
|
60
|
56
|
67
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
11
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
Baseline characteristics by cohort
| Measure |
CIN-107 Dose 1 (0.5mg)
n=69 Participants
CIN-107: CIN-107 tablets by mouth once daily
|
CIN-107 Dose 2 (1mg)
n=70 Participants
CIN-107: CIN-107 tablets by mouth once daily
|
CIN-107 Dose 3 (2mg)
n=67 Participants
CIN-107: CIN-107 tablets by mouth once daily
|
Placebo
n=69 Participants
Placebo: placebo tablets by mouth once daily
|
Total
n=275 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
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
151 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Age, Continuous
|
61.5 Years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
62.7 Years
STANDARD_DEVIATION 10.14 • n=7 Participants
|
61.2 Years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 10.78 • n=4 Participants
|
62.3 Years
STANDARD_DEVIATION 10.48 • n=21 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
153 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 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
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
191 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
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
67 participants
n=5 Participants
|
69 participants
n=4 Participants
|
275 participants
n=21 Participants
|
|
Seated SBP
|
147.6 mmHg
STANDARD_DEVIATION 12.49 • n=5 Participants
|
147.7 mmHg
STANDARD_DEVIATION 13.05 • n=7 Participants
|
147.3 mmHg
STANDARD_DEVIATION 11.82 • n=5 Participants
|
148.9 mmHg
STANDARD_DEVIATION 12.38 • n=4 Participants
|
147.9 mmHg
STANDARD_DEVIATION 12.40 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Only patients with non-missing baseline and the specified visit were included.
Outcome measures
| Measure |
mITT Population 0.5mg
n=65 Participants
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.
|
mITT Population 1mg
n=60 Participants
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.
|
mITT Population 2mg
n=54 Participants
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.
|
mITT Population Placebo
n=67 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Seated Systolic BP (SBP)
|
-12.4 mmHg
Standard Deviation 15.63
|
-17.3 mmHg
Standard Deviation 18.10
|
-19.2 mmHg
Standard Deviation 15.84
|
-9.8 mmHg
Standard Deviation 13.71
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only patients with non-missing baseline and the specified visit were included.
Outcome measures
| Measure |
mITT Population 0.5mg
n=65 Participants
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.
|
mITT Population 1mg
n=60 Participants
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.
|
mITT Population 2mg
n=54 Participants
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.
|
mITT Population Placebo
n=67 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Seated Diastolic BP (DBP)
|
-9.1 mmHg
Standard Deviation 9.04
|
-11.7 mmHg
Standard Deviation 9.88
|
-14.0 mmHg
Standard Deviation 12.42
|
-9.3 mmHg
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
Outcome measures
| Measure |
mITT Population 0.5mg
n=69 Participants
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.
|
mITT Population 1mg
n=69 Participants
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.
|
mITT Population 2mg
n=67 Participants
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.
|
mITT Population Placebo
n=69 Participants
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.
|
|---|---|---|---|---|
|
The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg
|
21 Participants
|
28 Participants
|
26 Participants
|
21 Participants
|
Adverse Events
Safety Population 0.5mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Safety Population 1mg
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Safety Population 2mg
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Safety Population Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population 0.5mg
n=69 participants at risk
The Safety Population included all patients who received at least 1 dose of any randomized study drug.
|
Safety Population 1mg
n=69 participants at risk
The Safety Population included all patients who received at least 1 dose of any randomized study drug.
|
Safety Population 2mg
n=67 participants at risk
The Safety Population included all patients who received at least 1 dose of any randomized study drug.
|
Safety Population Placebo
n=69 participants at risk
The Safety Population included all patients who received at least 1 dose of any randomized study drug.
|
|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/69 • 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.
|
1.4%
1/69 • Number of events 1 • 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.
|
0.00%
0/67 • 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.
|
1.4%
1/69 • Number of events 1 • 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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/69 • 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.
|
1.4%
1/69 • Number of events 1 • 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.
|
0.00%
0/67 • 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.
|
0.00%
0/69 • 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/69 • 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.
|
1.4%
1/69 • Number of events 1 • 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.
|
0.00%
0/67 • 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.
|
0.00%
0/69 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
0.00%
0/67 • 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.
|
1.4%
1/69 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/69 • 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.
|
Other adverse events
| Measure |
Safety Population 0.5mg
n=69 participants at risk
The Safety Population included all patients who received at least 1 dose of any randomized study drug.
|
Safety Population 1mg
n=69 participants at risk
The Safety Population included all patients who received at least 1 dose of any randomized study drug.
|
Safety Population 2mg
n=67 participants at risk
The Safety Population included all patients who received at least 1 dose of any randomized study drug.
|
Safety Population Placebo
n=69 participants at risk
The Safety Population included all patients who received at least 1 dose of any randomized study drug.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
4.3%
3/69 • 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.
|
10.1%
7/69 • 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.
|
9.0%
6/67 • 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.
|
4.3%
3/69 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
2/69 • 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.
|
7.2%
5/69 • 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.
|
3.0%
2/67 • 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.
|
1.4%
1/69 • 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.
|
|
General disorders
Fatigue
|
0.00%
0/69 • 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.
|
5.8%
4/69 • 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.
|
0.00%
0/67 • 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.
|
1.4%
1/69 • 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.
|
|
General disorders
Oedema peripheral
|
0.00%
0/69 • 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.
|
0.00%
0/69 • 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.
|
0.00%
0/67 • 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.
|
5.8%
4/69 • 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.
|
|
Nervous system disorders
Headache
|
1.4%
1/69 • 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.
|
7.2%
5/69 • 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.
|
0.00%
0/67 • 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.
|
2.9%
2/69 • 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.
|
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