DP13 - A Phase II Study in Patients With Primary Aldosteronism

Primary Aldosteronism Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007406
• Other study ID #: DP13C201
• Status: Completed
• Phase: Phase 2
• Start date: November 21, 2019
• Est. completion date: May 2, 2022

Study information

• Verified date: June 2022
• Source: Damian Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in 36 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Drug:
• DP13
DP13 systemic administration

Locations

Country	Name	City	State
Italy	Ospedale Molinette	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Damian Pharma AG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in potassium from baseline	Change in electrolytes	12 weeks
Other	Change in sodium from baseline	Change in electrolytes	12 weeks
Other	Steady state pharmacokinetics	Change in DP13 concentrations	8 weeks
Primary	Change in aldosterone	Change in aldosterone from baseline	8 weeks
Primary	Change in ambulatory blood pressure	Change in ambulatory blood pressure from baseline	8 weeks
Secondary	Occurrence of adverse events	Occurrence of treatment-emergent adverse events and serious adverse events over entire study duration	12 weeks
Secondary	Change in blood pressure	Change in blood pressure from baseline	12 weeks