DP13 - A Phase II Study in Patients With Primary Aldosteronism

NCT ID: NCT04007406

Last Updated: 2024-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-21

Study Completion Date

2022-05-02

Brief Summary

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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

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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

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Primary Aldosteronism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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4 mg DP13 daily

DP13 for 8 weeks

Group Type EXPERIMENTAL

dexfadrostat phosphate

Intervention Type DRUG

DP13 systemic administration

8 mg DP13 daily

DP13 for 8 weeks

Group Type EXPERIMENTAL

dexfadrostat phosphate

Intervention Type DRUG

DP13 systemic administration

12 mg DP13 daily

DP13 for 8 weeks

Group Type EXPERIMENTAL

dexfadrostat phosphate

Intervention Type DRUG

DP13 systemic administration

Interventions

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dexfadrostat phosphate

DP13 systemic administration

Intervention Type DRUG

Other Intervention Names

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DP13

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damian Pharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paolo Mulatero, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Torino, Torino, Italy

Locations

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Ospedale Molinette

Torino, , Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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DP13C201

Identifier Type: -

Identifier Source: org_study_id

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