Trial Outcomes & Findings for Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial) (NCT NCT04724837)
NCT ID: NCT04724837
Last Updated: 2024-07-30
Results Overview
The effect of zibotentan 1.5/dapagliflozin 10 mg versus dapagliflozin 10 mg on UACR was assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
542 participants
Primary outcome timeframe
From baseline (Week 0 [Day 1]) until Week 12 (Day 84)
Results posted on
2024-07-30
Participant Flow
The study was conducted in approximately 170 sites in North America, South America, Africa, Asia/Pacific, and European countries.
The screening period was of 4 weeks. All the study assessments were performed as per the schedule of assessments. Participants who met the eligibility criteria were randomised to study intervention. The reason of discrepancy between enrollment number versus subjects in the full analysis set and safety analysis set is that not all randomized subjects were included in analysis. Enrollment number is 542 when number of subjects included in the full analysis set and safety analysis set is 447.
Participant milestones
| Measure |
Zibotentan 0.25 mg + Dapagliflozin
Participants received once daily oral dose of 0.25 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Zibotentan 1.5 mg + Dapagliflozin
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
179
|
177
|
|
Overall Study
Full Analysis Set
|
91
|
179
|
177
|
|
Overall Study
Safety Analysis Set
|
91
|
179
|
177
|
|
Overall Study
COMPLETED
|
82
|
142
|
157
|
|
Overall Study
NOT COMPLETED
|
9
|
37
|
20
|
Reasons for withdrawal
| Measure |
Zibotentan 0.25 mg + Dapagliflozin
Participants received once daily oral dose of 0.25 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Zibotentan 1.5 mg + Dapagliflozin
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Other
|
4
|
16
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
9
|
9
|
|
Overall Study
Adverse Event
|
2
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Failure to Meet Randomization Criteria
|
0
|
1
|
3
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
1
|
0
|
Baseline Characteristics
Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
Baseline characteristics by cohort
| Measure |
Zibotentan 0.25 mg + Dapagliflozin
n=91 Participants
Participants received once daily oral dose of 0.25 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Zibotentan 1.5 mg + Dapagliflozin
n=179 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=177 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Total
n=447 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 12.72 • n=99 Participants
|
62.7 Years
STANDARD_DEVIATION 12.33 • n=107 Participants
|
63.6 Years
STANDARD_DEVIATION 11.60 • n=206 Participants
|
62.8 Years
STANDARD_DEVIATION 12.13 • n=7 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
309 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
127 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
320 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
305 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From baseline (Week 0 [Day 1]) until Week 12 (Day 84)Population: The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.
The effect of zibotentan 1.5/dapagliflozin 10 mg versus dapagliflozin 10 mg on UACR was assessed.
Outcome measures
| Measure |
Zibotentan 1.5 mg + Dapagliflozin
n=105 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=132 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Placebo + Dapagliflozin
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
|
0.48 milligram/gram (mg/g)
Standard Error 1.094
|
0.72 milligram/gram (mg/g)
Standard Error 1.090
|
—
|
SECONDARY outcome
Timeframe: From baseline (Week 0 [Day 1]) until Week 12Population: The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.
The effect of zibotentan 0.25 mg/dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy on UACR was assessed.
Outcome measures
| Measure |
Zibotentan 1.5 mg + Dapagliflozin
n=62 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=132 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Placebo + Dapagliflozin
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Change in UACR From Baseline to Week 12
|
0.52 mg/g
Standard Error 1.106
|
0.72 mg/g
Standard Error 1.090
|
—
|
SECONDARY outcome
Timeframe: From baseline (Week 0 [Day 1]) until Week 12 (Day 84)Population: The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.
The change in office systolic blood pressure for doses of zibotentan combined with dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy was assessed.
Outcome measures
| Measure |
Zibotentan 1.5 mg + Dapagliflozin
n=65 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=108 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Placebo + Dapagliflozin
n=137 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Change in Office Systolic Blood Pressure From Baseline to Week 12
|
-7.1 Millimeters of mercury (mmHg)
Interval -10.0 to -4.1
|
-11.0 Millimeters of mercury (mmHg)
Interval -13.5 to -8.4
|
-3.4 Millimeters of mercury (mmHg)
Interval -5.8 to -1.0
|
SECONDARY outcome
Timeframe: From baseline (Week 0 [Day 1]) until Week 12 (Day 84)Population: The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.
The change in office diastolic blood pressure for doses of zibotentan combined with dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy was assessed.
Outcome measures
| Measure |
Zibotentan 1.5 mg + Dapagliflozin
n=65 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=108 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Placebo + Dapagliflozin
n=137 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Change in Office Diastolic Blood Pressure From Baseline to Week 12
|
-4.3 mmHg
Interval -6.2 to -2.5
|
-6.8 mmHg
Interval -8.4 to -5.2
|
-1.4 mmHg
Interval -2.9 to 0.1
|
SECONDARY outcome
Timeframe: From baseline (Week 0 [Day 1]) until Week 12 (Day 84)Population: The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.
The assessment of dose-response and relationship across different dose of zibotentan/dapagliflozin and dapagliflozin alone on UACR reduction.
Outcome measures
| Measure |
Zibotentan 1.5 mg + Dapagliflozin
n=62 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=105 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Placebo + Dapagliflozin
n=132 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Change in UACR From Baseline to Week 12
|
0.52 mg/g
Standard Error 1.106
|
0.48 mg/g
Standard Error 1.094
|
0.72 mg/g
Standard Error 1.090
|
SECONDARY outcome
Timeframe: From baseline (Week 0 [Day 1]) until Week 1 (Day 8), Week 12 (Day 84), and Week 14 (Day 98)Population: The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.
The effect of different doses of zibotentan and dapagliflozin 10 mg in combination versus dapagliflozin 10 mg monotherapy on eGFR was assessed.
Outcome measures
| Measure |
Zibotentan 1.5 mg + Dapagliflozin
n=83 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=152 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Placebo + Dapagliflozin
n=151 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Change in eGFR From Baseline to Week 1, Week 12, and Week 14
Week 1
|
-2.0 milliliters/minutes/1.73 square metres
Interval -3.5 to -0.5
|
-3.9 milliliters/minutes/1.73 square metres
Interval -5.2 to -2.6
|
-3.1 milliliters/minutes/1.73 square metres
Interval -4.4 to -1.8
|
|
Change in eGFR From Baseline to Week 1, Week 12, and Week 14
Week 12
|
-3.1 milliliters/minutes/1.73 square metres
Interval -4.7 to -1.5
|
-3.0 milliliters/minutes/1.73 square metres
Interval -4.4 to -1.6
|
-1.9 milliliters/minutes/1.73 square metres
Interval -3.3 to -0.6
|
|
Change in eGFR From Baseline to Week 1, Week 12, and Week 14
Week 14
|
0.2 milliliters/minutes/1.73 square metres
Interval -1.4 to 1.8
|
-2.0 milliliters/minutes/1.73 square metres
Interval -3.4 to -0.6
|
0.1 milliliters/minutes/1.73 square metres
Interval -1.2 to 1.5
|
SECONDARY outcome
Timeframe: From Screening (Day -28) until Follow-up visit (Day 98), up to 126 daysPopulation: The safety analysis set included all participants that were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.
The safety and tolerability of all doses of zibotentan combined with dapagliflozin 10 mg and dapagliflozin 10 mg monotherapy was assessed.
Outcome measures
| Measure |
Zibotentan 1.5 mg + Dapagliflozin
n=91 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=179 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Placebo + Dapagliflozin
n=177 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE possibly related to IP
|
14 Participants
|
33 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE
|
45 Participants
|
86 Participants
|
66 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE with outcome of death
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any SAE
|
2 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE leading to discontinuation of investigational product (IP)
|
11 Participants
|
22 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE leading to dose interruption
|
3 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE leading to withdrawal from study
|
2 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Week 1 (Day 8) to Week 12 (Day 84)Population: The full analysis set included all participants who were randomised and received any study intervention. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.
The effect of different doses of zibotentan and dapagliflozin 10 mg in combination versus dapagliflozin 10 mg monotherapy on eGFR was assessed.
Outcome measures
| Measure |
Zibotentan 1.5 mg + Dapagliflozin
n=64 Participants
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=108 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
Placebo + Dapagliflozin
n=135 Participants
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Change in eGFR From Week 1 to Week 12
|
-1.1 milliliters/minutes/1.73 square metres
Interval -2.5 to 0.4
|
0.9 milliliters/minutes/1.73 square metres
Interval -0.2 to 2.0
|
1.2 milliliters/minutes/1.73 square metres
Interval 0.1 to 2.2
|
Adverse Events
Zibotentan 0.25 mg + Dapagliflozin
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Zibotentan 1.5 mg + Dapagliflozin
Serious events: 10 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo + Dapagliflozin
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Zibotentan 0.25 mg + Dapagliflozin
n=91 participants at risk
Participants received once daily oral dose of 0.25 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Zibotentan 1.5 mg + Dapagliflozin
n=179 participants at risk
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=177 participants at risk
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/179 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/177 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/179 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/177 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/91 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/179 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/91 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/179 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/177 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
General disorders
Fatigue
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
General disorders
Sudden cardiac death
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/179 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/177 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/91 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/179 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/177 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
Other adverse events
| Measure |
Zibotentan 0.25 mg + Dapagliflozin
n=91 participants at risk
Participants received once daily oral dose of 0.25 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Zibotentan 1.5 mg + Dapagliflozin
n=179 participants at risk
Participants received once daily oral dose of 1.5 mg zibotentan and 10 mg dapagliflozin for 12 weeks.
|
Placebo + Dapagliflozin
n=177 participants at risk
Participants received once daily oral dose of dapagliflozin 10 mg and matching placebo for 12 weeks.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.5%
5/91 • Number of events 5 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
3.9%
7/179 • Number of events 8 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
1.1%
2/177 • Number of events 2 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Nervous system disorders
Headache
|
6.6%
6/91 • Number of events 6 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
4.5%
8/179 • Number of events 9 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
1.1%
2/177 • Number of events 2 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Vascular disorders
Hypertension
|
5.5%
5/91 • Number of events 5 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.00%
0/179 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/177 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
|
Investigations
Brain natriuretic peptide increased
|
2.2%
2/91 • Number of events 2 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
5.0%
9/179 • Number of events 9 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
0.56%
1/177 • Number of events 1 • From screening (Day -28) to Final Follow-up (Day 98), up to 126 days
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Phone: 1-877-240-94
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER