Trial Outcomes & Findings for DP13 - A Phase II Study in Patients With Primary Aldosteronism (NCT NCT04007406)
NCT ID: NCT04007406
Last Updated: 2024-11-22
Results Overview
Change from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-11-22
Participant Flow
Patients were recruited 'de novo' i.e., diagnosed with Primary Aldosteronism within 10 weeks of study entry or as 'recently diagnosed' i.e., diagnosed between 10 weeks and 1 year prior to study entry
Patient screening ARR and BP were reviewed and approved by the Eligibility Review Panel prior to study enrollment. A suppression test was required prior to study entry to confirm PA diagnosis. Patients had a 2-week placebo run-in prior to randomization.
Participant milestones
| Measure |
4 mg DP13
Patients receiving the low dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast
|
8 mg DP13
Patients receiving the middle dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast
|
12 mg DP13
Patients receiving the high dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DP13 - A Phase II Study in Patients With Primary Aldosteronism
Baseline characteristics by cohort
| Measure |
4 mg DP13
n=10 Participants
Baseline values were determined following 2 weeks of single-blind placebo run-in
|
8 mg DP13
n=12 Participants
Baseline values were determined following 2 weeks of single-blind placebo run-in
|
12 mg DP13
n=13 Participants
Baseline values were determined following 2 weeks of single-blind placebo run-in
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
Italy
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Office systolic blood pressure (oSBP)
|
147 mmHg
STANDARD_DEVIATION 14 • n=5 Participants
|
148 mmHg
STANDARD_DEVIATION 6 • n=7 Participants
|
148 mmHg
STANDARD_DEVIATION 14 • n=5 Participants
|
148 mmHg
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Office diastolic blood pressure (oDBP)
|
90 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
95 mmHg
STANDARD_DEVIATION 9 • n=7 Participants
|
92 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
92 mmHg
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Aldosterone-to-renin ratio (ARR)
|
21.4 ng*L/dL*mU
n=5 Participants
|
7.2 ng*L/dL*mU
n=7 Participants
|
17.8 ng*L/dL*mU
n=5 Participants
|
15.3 ng*L/dL*mU
n=4 Participants
|
|
24-hour ambulatory systolic blood pressure (aSBP)
|
137 mmHg
STANDARD_DEVIATION 16 • n=5 Participants
|
145 mmHg
STANDARD_DEVIATION 14 • n=7 Participants
|
145 mmHg
STANDARD_DEVIATION 13 • n=5 Participants
|
143 mmHg
STANDARD_DEVIATION 14 • n=4 Participants
|
|
24-hour ambulatory diastolic blood pressure (aDBP)
|
84 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
90 mmHg
STANDARD_DEVIATION 7 • n=7 Participants
|
89 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
88 mmHg
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Potassium
|
3.36 mmol/L
STANDARD_DEVIATION 0.45 • n=5 Participants
|
3.55 mmol/L
STANDARD_DEVIATION 0.31 • n=7 Participants
|
3.54 mmol/L
STANDARD_DEVIATION 0.41 • n=5 Participants
|
3.49 mmol/L
STANDARD_DEVIATION 0.39 • n=4 Participants
|
|
24-hour Urinary Tetrahydroaldosterone Content (uTHA)
|
80.0 ug/24h
n=5 Participants
|
59.5 ug/24h
n=7 Participants
|
69.0 ug/24h
n=5 Participants
|
67.0 ug/24h
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksChange from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group.
Outcome measures
| Measure |
4 mg DP13
n=10 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
8 mg DP13
n=12 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
12 mg DP13
n=13 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
All Dose Arms Combined
n=35 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
|---|---|---|---|---|
|
Change in Aldosterone-to-renin Ratio
|
-15.0 ng*L/dL*mU
Interval -25.5 to -5.7
|
-7.0 ng*L/dL*mU
Interval -16.0 to -2.7
|
-14.0 ng*L/dL*mU
Interval -20.8 to -8.4
|
-11.8 ng*L/dL*mU
Interval -23.8 to -4.9
|
PRIMARY outcome
Timeframe: 8 weeksAll patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined.
Outcome measures
| Measure |
4 mg DP13
n=10 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
8 mg DP13
n=12 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
12 mg DP13
n=13 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
All Dose Arms Combined
n=35 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
|---|---|---|---|---|
|
Change in Ambulatory Systolic Blood Pressure
|
-8 mm Hg
Standard Deviation 10
|
-14 mm Hg
Standard Deviation 8
|
-10 mm Hg
Standard Deviation 9
|
-11 mm Hg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 8 weeksChange from baseline after 8 weeks of treatment with dexfadrostat phosphate
Outcome measures
| Measure |
4 mg DP13
n=10 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
8 mg DP13
n=12 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
12 mg DP13
n=13 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
All Dose Arms Combined
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
|---|---|---|---|---|
|
Change in Potassium
|
0.74 mmol/L
Standard Deviation 0.51
|
0.55 mmol/L
Standard Deviation 0.29
|
0.28 mmol/L
Standard Deviation 0.55
|
—
|
SECONDARY outcome
Timeframe: 8 weeksChange from baseline following 8-weeks of dexfadrostat phosphate treatment
Outcome measures
| Measure |
4 mg DP13
n=10 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
8 mg DP13
n=12 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
12 mg DP13
n=13 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
All Dose Arms Combined
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
|---|---|---|---|---|
|
Change in Ambulatory Diastolic Blood Pressure
|
-4.5 mm Hg
Standard Deviation 7.0
|
-7.9 mm Hg
Standard Deviation 6.4
|
-4.5 mm Hg
Standard Deviation 7.0
|
—
|
SECONDARY outcome
Timeframe: 8 weeksChange from baseline in urinary tetrahydroaldosterone content (uTHA) following 8 weeks of treatment with dexfadrostat phosphate
Outcome measures
| Measure |
4 mg DP13
n=10 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
8 mg DP13
n=12 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
12 mg DP13
n=13 Participants
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
All Dose Arms Combined
Values are after 8 weeks of treatment with dexfadrostat phosphate
|
|---|---|---|---|---|
|
Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)
|
-61.0 ug/24 hour urine
Interval -86.0 to -45.0
|
-50.0 ug/24 hour urine
Interval -74.0 to -28.5
|
-66.0 ug/24 hour urine
Interval -71.0 to -41.0
|
—
|
Adverse Events
4 mg DP13
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
8 mg DP13
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
12 mg DP13
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
4 mg DP13
n=10 participants at risk
Patients receiving low dose dexfadrostat phosphate daily for 8 weeks
|
8 mg DP13
n=12 participants at risk
Patients receiving middle dose dexfadrostat phosphate daily for 8 weeks
|
12 mg DP13
n=13 participants at risk
Patients receiving high dose dexfadrostat phosphate daily for 8 weeks
|
|---|---|---|---|
|
Investigations
Amylase increase
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Investigations
Blood lactate dehydrogenase increase
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Investigations
Blood pressure diastolic increase
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 4 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
16.7%
2/12 • Number of events 2 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
15.4%
2/13 • Number of events 2 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 2 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Cardiac disorders
Lower limb edema
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
8.3%
1/12 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/13 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric leiomyoma
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
0.00%
0/12 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
|
Additional Information
Teresa Gerlock/Chief Operations Officer
DAMIAN Pharma AG
Phone: +41 79 230 8591
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place