NCT04007406

DP13 - A Phase II Study in Patients With Primary Aldosteronism

DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Damian Pharma AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Aldosteronism

Interventions

Type	Name	Description
DRUG	dexfadrostat phosphate	DP13 systemic administration

Timeline

• Start date: 2019-11-21
• Primary completion: 2022-05-02
• Completion: 2022-05-02
• First posted: 2019-07-05
• Last updated: 2024-11-22
• Results posted: 2024-11-22

Locations

1 site across 1 country: Italy