Primary AldosteronismPhase 2NCT04007406
DP13 - A Phase II Study in Patients With Primary Aldosteronism
A Phase 2 study testing dexfadrostat phosphate in people with Primary Aldosteronism, run by Damian Pharma AG at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- dexfadrostat phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2019to 2 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a guideline-recommended diagnosis of primary aldosteronism
Who cannot join
- Patients with primary aldosteronism and
- hyperkalemia
- prolonged QT intervals
- refusal of special contraception measures
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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
- Primary Aldosteronism
- Being tested
- dexfadrostat phosphate
- Keywords
- Hyperaldosteronism
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexfadrostat phosphateDrug
Also called DP13
DP13 systemic administration
| Study group | Role | What they receive |
|---|---|---|
| 4 mg DP13 daily | Experimental | DP13 for 8 weeks Receives: Drug: dexfadrostat phosphate |
| 8 mg DP13 daily | Experimental | DP13 for 8 weeks Receives: Drug: dexfadrostat phosphate |
| 12 mg DP13 daily | Experimental | DP13 for 8 weeks Receives: Drug: dexfadrostat phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Change in Ambulatory Systolic Blood Pressure
All patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined.
Measured: 8 weeks
Secondary outcomes (3)
Change in Potassium
Change from baseline after 8 weeks of treatment with dexfadrostat phosphate
Measured: 8 weeks
Change in Ambulatory Diastolic Blood Pressure
Change from baseline following 8-weeks of dexfadrostat phosphate treatment
Measured: 8 weeks
Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)
Change from baseline in urinary tetrahydroaldosterone content (uTHA) following 8 weeks of treatment with dexfadrostat phosphate
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start21 Nov 2019
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damian Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Mulatero, Prof, Principal investigator, University of Torino, Torino, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007406
- Sponsor's protocol ID
- DP13C201
- Status last verified
- Oct 2024
- First submitted
- 1 Jul 2019
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04007406
- Acronym / sponsor ID
- DP13C201
- Conditions
- Primary Aldosteronism
- Keywords
- Hyperaldosteronism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Damian Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 mg DP13 daily | Experimental | Drug: dexfadrostat phosphateDP13 for 8 weeks |
| 8 mg DP13 daily | Experimental | Drug: dexfadrostat phosphateDP13 for 8 weeks |
| 12 mg DP13 daily | Experimental | Drug: dexfadrostat phosphateDP13 for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a guideline-recommended diagnosis of primary aldosteronism
Key exclusion criteria (4 listed)
- Patients with primary aldosteronism and
- hyperkalemia
- prolonged QT intervals
- refusal of special contraception measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexfadrostat phosphateAlso: DP13DP13 systemic administration | Drug | 12 mg DP13 daily, 4 mg DP13 daily, 8 mg DP13 daily |
Primary outcome
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.
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.
3 secondary outcomes
Change in Potassium
Time frame: 8 weeks
Change in Ambulatory Diastolic Blood Pressure
Time frame: 8 weeks
Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Mulatero, Prof principal investigator
University of Torino, Torino, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexfadrostat phosphate in people with Primary Aldosteronism, run by Damian Pharma AG at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aldosterone-to-renin Ratio (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.