Phase 2
N=35
DP13 - A Phase II Study in Patients With Primary Aldosteronism
Primary Aldosteronism
Bottom Line
View on ClinicalTrials.gov: NCT04007406 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in Aldosterone-to-renin Ratio — -15.0; -7.0; -14.0; -11.8 ng*L/dL*mU — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dexfadrostat phosphate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Damian Pharma AG
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Aldosterone-to-renin Ratio |
-15.0; -7.0; -14.0; -11.8 | <0.0001 sig |
| PRIMARY Change in Ambulatory Systolic Blood Pressure |
-8; -14; -10; -11 | <0.0001 sig |
| SECONDARY Change in Potassium |
0.74; 0.55; 0.28 | <0.0001 sig |
| SECONDARY Change in Ambulatory Diastolic Blood Pressure |
-4.5; -7.9; -4.5 | <0.0001 sig |
| SECONDARY Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA) |
-61.0; -50.0; -66.0 | <0.0001 sig |
Summary
The purpose of the present phase II study is to determine whether DP13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.
Eligibility Criteria
Inclusion Criteria
Patients with a guideline-recommended diagnosis of primary aldosteronism
Exclusion Criteria
Patients with primary aldosteronism and
- hyperkalemia
- prolonged QT intervals
- refusal of special contraception measures
Data sourced from ClinicalTrials.gov (NCT04007406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.