DP13 - A Phase II Study in Patients With Primary Aldosteronism
1 other identifier
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
November 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2022
CompletedResults Posted
Study results publicly available
November 22, 2024
CompletedNovember 22, 2024
October 1, 2024
2.4 years
July 1, 2019
December 6, 2023
October 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Change in Potassium
8 weeks
Change in Ambulatory Diastolic Blood Pressure
8 weeks
Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)
8 weeks
Study Arms (3)
4 mg DP13 daily
EXPERIMENTALDP13 for 8 weeks
8 mg DP13 daily
EXPERIMENTALDP13 for 8 weeks
12 mg DP13 daily
EXPERIMENTALDP13 for 8 weeks
Interventions
DP13 systemic administration
Eligibility Criteria
You may qualify if:
- Patients with a guideline-recommended diagnosis of primary aldosteronism
You may not qualify if:
- Patients with primary aldosteronism and
- hyperkalemia
- prolonged QT intervals
- refusal of special contraception measures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Damian Pharma AGlead
Study Sites (1)
Ospedale Molinette
Torino, 10126, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Teresa Gerlock/Chief Operations Officer
- Organization
- DAMIAN Pharma AG
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Mulatero, Prof
University of Torino, Torino, Italy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 5, 2019
Study Start
November 21, 2019
Primary Completion
May 2, 2022
Study Completion
May 2, 2022
Last Updated
November 22, 2024
Results First Posted
November 22, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share