DP13 - A Phase II Study in Patients With Primary Aldosteronism

Damian Pharma

Status and phase: Completed; Phase 2

Conditions: Primary Aldosteronism

Treatments: Drug: dexfadrostat phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04007406

DP13C201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups

4 mg DP13 daily

Experimental group

Description:

DP13 for 8 weeks

Treatment:

Drug: dexfadrostat phosphate

8 mg DP13 daily

Experimental group

Description:

DP13 for 8 weeks

Treatment:

Drug: dexfadrostat phosphate

12 mg DP13 daily

Experimental group

Description:

DP13 for 8 weeks

Treatment:

Drug: dexfadrostat phosphate