DP13 - A Phase II Study in Patients With Primary Aldosteronism

Phase 2

Completed

• Conditions: Primary Aldosteronism
• Interventions: Drug: dexfadrostat phosphate

• Registration Number: NCT04007406
• Lead Sponsor: Damian Pharma AG

Brief 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.

Detailed Description

A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in patients with primary aldosteronism to determine the dose-dependent efficacy, safety and tolerability of DP13 after a 2-week single-blind placebo run-in period followed by a randomized 8-week double-blind treatment period. After an additional single-blind, 2-week DP13 placebo withdrawal period, patients are switched to standard of care.

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2019-11-21
• Primary Completion: 2022-05-02
• Study Completion: 2022-05-02
• Results First Submitted: 2023-12-06
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Results First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 mg DP13 daily	dexfadrostat phosphate	DP13 for 8 weeks
8 mg DP13 daily	dexfadrostat phosphate	DP13 for 8 weeks
12 mg DP13 daily	dexfadrostat phosphate	DP13 for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Aldosterone-to-renin Ratio	8 weeks	Change from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group.
Change in Ambulatory Systolic Blood Pressure	8 weeks	All patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined.

Secondary Outcome Measures

Name	Time	Method
Change in Potassium	8 weeks	Change from baseline after 8 weeks of treatment with dexfadrostat phosphate
Change in Ambulatory Diastolic Blood Pressure	8 weeks	Change from baseline following 8-weeks of dexfadrostat phosphate treatment
Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)	8 weeks	Change from baseline in urinary tetrahydroaldosterone content (uTHA) following 8 weeks of treatment with dexfadrostat phosphate

Trial Locations

Locations (1)

Ospedale Molinette; 🇮🇹 Torino, Italy