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

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.

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Drug: dexfadrostat phosphate

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10126
    • Ospedale Molinette

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 mg DP13 daily; DP13 for 8 weeks	Drug: dexfadrostat phosphate; DP13 systemic administration; Other Names: DP13
Experimental: 8 mg DP13 daily; DP13 for 8 weeks	Drug: dexfadrostat phosphate; DP13 systemic administration; Other Names: DP13
Experimental: 12 mg DP13 daily; DP13 for 8 weeks	Drug: dexfadrostat phosphate; DP13 systemic administration; Other Names: DP13

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in potassium from baseline	Change in electrolytes	12 weeks
Change in sodium from baseline	Change in electrolytes	12 weeks
Steady state pharmacokinetics	Change in DP13 concentrations	8 weeks

Collaborators and Investigators

• Sponsor: Damian Pharma AG
• Investigators: Principal Investigator: Paolo Mulatero, Prof, University of Torino, Torino, Italy

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Actual): May 2, 2022
• Study Completion (Actual): May 2, 2022

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Hyperaldosteronism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism
• Other Study ID Numbers: DP13C201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No