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Completed

NCT Number: NCT04007406

DP13 - A Phase II Study in Patients With Primary Aldosteronism

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.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale Molinette

Torino, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexfadrostat phosphate

Drug

DP13 systemic administration

Other names: DP13

Primary outcomes

  1. Change in Aldosterone-to-renin Ratio

    Time frame: 8 weeks

    Change from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group.

  2. Change in Ambulatory Systolic Blood Pressure

    Time frame: 8 weeks

    All patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined.

Secondary outcomes

  1. Change in Potassium

    Time frame: 8 weeks

    Change from baseline after 8 weeks of treatment with dexfadrostat phosphate

  2. Change in Ambulatory Diastolic Blood Pressure

    Time frame: 8 weeks

    Change from baseline following 8-weeks of dexfadrostat phosphate treatment

  3. Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)

    Time frame: 8 weeks

    Change from baseline in urinary tetrahydroaldosterone content (uTHA) following 8 weeks of treatment with dexfadrostat phosphate

Sponsors and collaborators

Lead sponsor

Damian Pharma AG

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2019
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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