Back to resultsDP13 - A Phase II Study in Patients With Primary Aldosteronism
Primary Purpose
Primary Aldosteronism
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
DP13
Sponsored by
About this trial
This is an interventional treatment trial for Primary Aldosteronism
Eligibility Criteria
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
Sites / Locations
- Ospedale Molinette
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
DP13 low
DP13 middle
DP13 high
Arm Description
DP13 for 8 weeks
DP13 for 8 weeks
DP13 for 8 weeks
Outcomes
Primary Outcome Measures
Change in aldosterone
Change in aldosterone from baseline
Change in ambulatory blood pressure
Change in ambulatory blood pressure from baseline
Secondary Outcome Measures
Occurrence of adverse events
Occurrence of treatment-emergent adverse events and serious adverse events over entire study duration
Change in blood pressure
Change in blood pressure from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04007406
Brief Title
DP13 - A Phase II Study in Patients With Primary Aldosteronism
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
May 2, 2022 (Actual)
Study Completion Date
May 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damian Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DP13 low
Arm Type
Experimental
Arm Description
DP13 for 8 weeks
Arm Title
DP13 middle
Arm Type
Experimental
Arm Description
DP13 for 8 weeks
Arm Title
DP13 high
Arm Type
Experimental
Arm Description
DP13 for 8 weeks
Intervention Type
Drug
Intervention Name(s)
DP13
Intervention Description
DP13 systemic administration
Primary Outcome Measure Information:
Title
Change in aldosterone
Description
Change in aldosterone from baseline
Time Frame
8 weeks
Title
Change in ambulatory blood pressure
Description
Change in ambulatory blood pressure from baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Description
Occurrence of treatment-emergent adverse events and serious adverse events over entire study duration
Time Frame
12 weeks
Title
Change in blood pressure
Description
Change in blood pressure from baseline
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in potassium from baseline
Description
Change in electrolytes
Time Frame
12 weeks
Title
Change in sodium from baseline
Description
Change in electrolytes
Time Frame
12 weeks
Title
Steady state pharmacokinetics
Description
Change in DP13 concentrations
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ospedale Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DP13 - A Phase II Study in Patients With Primary Aldosteronism
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