Trial Outcomes & Findings for The ORTIZ Study: Optimising RASi Therapy With SZC (NCT NCT04983979)
NCT ID: NCT04983979
Last Updated: 2025-06-08
Results Overview
Difference in proportion of patients on maximum dose (300mg) Irbesartan therapy at the end of 12 weeks compared to placebo. Proportion is calculated per arm as number of individuals on maximum dose Irbesatan therapy divided by the number of individuals in the study arm. The difference in proportion is calculated as experimental arm - placebo comparator arm.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Study end (week 12)
Results posted on
2025-06-08
Participant Flow
After patient enrolment, patients were checked for eligibility, then randomized to either Arm A or B if eligible. 18 participants were consented for inclusion in ORTIZ. 7 participants failed screening as they did not meet the inclusion criteria. Two participants were not randomised despite being eligible. One participant was deemed to be unable to comply with the study schedule. The other was screened and found to be eligible 2 days prior to study termination so was not randomised.
Participant milestones
| Measure |
Experimental: SZC
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
|
Placebo Comparator: Placebo
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The ORTIZ Study: Optimising RASi Therapy With SZC
Baseline characteristics by cohort
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
58.0 years
STANDARD_DEVIATION 14.2 • n=107 Participants
|
57.8 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Type of Medical Histpry
Diabetes
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Type of Medical Histpry
Hypertension
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Type of Medical Histpry
Kidney disease
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Type of Medical Histpry
Other
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Type of Medical Histpry
Unknown
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Study end (week 12)Population: Patients with diabetic kidney disease
Difference in proportion of patients on maximum dose (300mg) Irbesartan therapy at the end of 12 weeks compared to placebo. Proportion is calculated per arm as number of individuals on maximum dose Irbesatan therapy divided by the number of individuals in the study arm. The difference in proportion is calculated as experimental arm - placebo comparator arm.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
|---|---|---|
|
Proportion of Patients on Maximum Dose (300mg) Irbesartan Therapy at 12 Weeks Compared to Placebo
Number of participants reaching maximum dose of irbesartan
|
2 Participants
|
3 Participants
|
|
Proportion of Patients on Maximum Dose (300mg) Irbesartan Therapy at 12 Weeks Compared to Placebo
Number of participants with no available data on irbesartan dose
|
1 Participants
|
0 Participants
|
|
Proportion of Patients on Maximum Dose (300mg) Irbesartan Therapy at 12 Weeks Compared to Placebo
Number of participants who did not reach maximum dose of irbesartan
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At each study visit (weeks 1, 2, 4, 6, 8,12)Population: Patients with diabetic kidney disease
Difference in potassium from baseline at each study visit (weeks 1, 2, 4, 6, 8,12) calculated as a mean for each study visit.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
|---|---|---|
|
Change in Potassium From Baseline at Each Time Point
Week 1
|
-0.58 mmol/L
Standard Deviation 0.53
|
0.06 mmol/L
Standard Deviation 0.42
|
|
Change in Potassium From Baseline at Each Time Point
Week 2
|
-0.03 mmol/L
Standard Deviation 0.45
|
0.24 mmol/L
Standard Deviation 0.54
|
|
Change in Potassium From Baseline at Each Time Point
Week 4
|
0.10 mmol/L
Standard Deviation 0.23
|
0.08 mmol/L
Standard Deviation 0.36
|
|
Change in Potassium From Baseline at Each Time Point
Week 6
|
-0.10 mmol/L
Standard Deviation 0.54
|
0.16 mmol/L
Standard Deviation 0.23
|
|
Change in Potassium From Baseline at Each Time Point
Week 8
|
0.05 mmol/L
Standard Deviation 0.52
|
0.16 mmol/L
Standard Deviation 0.52
|
|
Change in Potassium From Baseline at Each Time Point
Week 12
|
-0.50 mmol/L
Standard Deviation 0.50
|
0.16 mmol/L
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Study end (week 12)Population: Patients with diabetic kidney disease
Difference in systolic and diastolic BP from baseline to end of study follow-up (week 12) calculated as a mean for each study visit.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
|---|---|---|
|
Change in the BP at the End of the Study From Baseline
Systolic BP
|
-3.75 mmHg
Standard Deviation 26.80
|
-28.90 mmHg
Standard Deviation 28.20
|
|
Change in the BP at the End of the Study From Baseline
Diastolic BP
|
1.38 mmHg
Standard Deviation 10.54
|
-7.40 mmHg
Standard Deviation 12.75
|
SECONDARY outcome
Timeframe: Cumulative across study follow-up, assessed at study end (week 12)Population: Patients with diabetic kidney disease.
Difference in proportion of patients who have a potassium of \>6mmol/l,, or \>6.5mmol/l at any time during the study. Proportion is calculated per arm as number of individuals with a maximum potassium across study follow-up of \>6mmol/l or \>6.5mmol/l divided by the number of individuals in the study arm. The difference in proportion is calculated as experimental arm - placebo comparator arm.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
|---|---|---|
|
Proportion of Patients Who Have a Potassium of >6mmol/l, or >6.5mmol/l at Any Time During the Study
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cumulative across study follow-up, assessed at study end (week 12)Population: Patients with diabetic kidney disease
Difference in proportion of patients who have a potassium of \<3.5mmol/l at any time during the study. Proportion is calculated per arm as number of individuals with a minimum potassium of \<3.5mmol/l across study follow-up divided by the number of individuals in the study arm. The difference in proportion is calculated as experimental arm - placebo comparator arm.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
|---|---|---|
|
Proportion of Patients Who Have a Potassium of <3.5mmol/l •
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cumulative. Calculated at each study visit. Assessed at study end (week 12).Population: Patients with diabetic kidney disease
Difference in proportion of patients with a sudden drop in GFR defined as \>30% decreased between study visits. Proportion is calculated per arm as number of individuals experiencing a sudden drop of GFR divided by the number of individuals in the study arm. The difference in proportion is calculated as experimental arm - placebo comparator arm.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
|---|---|---|
|
Proportion of Patients Whose Glomerular Filtration Rate (GFR) Falls by >30% From the Previous Visit •
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study end (week 12)Population: Patients with diabetic kidney disease
Difference in GFR from baseline to end of study follow-up (week 12) calculated as a mean for each study visit.
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
|---|---|---|
|
Change in GFR at the End of Study From Baseline
eGFR at Baseline
|
41.00 mL/min/1.73m^2
Standard Deviation 18.49
|
42.80 mL/min/1.73m^2
Standard Deviation 12.58
|
|
Change in GFR at the End of Study From Baseline
eGFR at 12 weeks
|
35.00 mL/min/1.73m^2
Standard Deviation 16.19
|
40.80 mL/min/1.73m^2
Standard Deviation 7.79
|
|
Change in GFR at the End of Study From Baseline
Difference from baseline
|
-6.0 mL/min/1.73m^2
Standard Deviation 2.83
|
-2.00 mL/min/1.73m^2
Standard Deviation 7.28
|
SECONDARY outcome
Timeframe: Study end (week 12)A count of the number of adverse events reported in each study arm
Outcome measures
| Measure |
Sodium Zirconium Cyclosilicate (SZC)
n=4 Participants
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Sodium Zirconium Cyclosilicate: sachets of 5g or 10g given OD titrated to serum potassium
|
Placebo
n=5 Participants
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
Placebo: matched placebo given titrated according to potassium at a dose to 5 or 10g
|
|---|---|---|
|
Frequency of Adverse Events
|
6 adverse events across participants
|
6 adverse events across participants
|
Adverse Events
Experimental: SZC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Comparator: Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: SZC
n=4 participants at risk
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
|
Placebo Comparator: Placebo
n=5 participants at risk
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
|
|---|---|---|
|
Surgical and medical procedures
Broken left humerus
|
0.00%
0/4 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
20.0%
1/5 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
Other adverse events
| Measure |
Experimental: SZC
n=4 participants at risk
3 month treatment using Sodium zirconium cyclocilicate. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
|
Placebo Comparator: Placebo
n=5 participants at risk
3 month treatment using matched placebo. Doses of 5 or 10g once daily will be used. The dose will be titrated according to potassium levels performed at clinic visits
|
|---|---|---|
|
Blood and lymphatic system disorders
Oedema
|
0.00%
0/4 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
20.0%
1/5 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
Gastrointestinal disorders
Stomach Cramps
|
25.0%
1/4 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
0.00%
0/5 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
Cardiac disorders
Bradycardia
|
25.0%
1/4 • Number of events 2 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
0.00%
0/5 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
20.0%
1/5 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
Blood and lymphatic system disorders
Hypoglycaemia
|
25.0%
1/4 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
20.0%
1/5 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
25.0%
1/4 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
0.00%
0/5 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
25.0%
1/4 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
0.00%
0/5 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
Endocrine disorders
Fluid overload
|
0.00%
0/4 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
20.0%
1/5 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
General disorders
Weight gain
|
0.00%
0/4 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
20.0%
1/5 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
|
Cardiac disorders
Worsening hypertension
|
0.00%
0/4 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
20.0%
1/5 • Number of events 1 • 16 weeks
AE: Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs that do not require reporting Specific biochemical and physiological parameters (potassium, BP, creatinine) will be expected to be altered as part of the predefined protocol and would not be expected to be reported as AEs: with the exception of those associated with an SAE or an AESI.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place