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4 mg DP13 daily for Conn's syndrome

Phase 2
Waitlist Available
Led By Paolo Mulatero, Prof
Research Sponsored by Damian Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a guideline-recommended diagnosis of primary aldosteronism
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment called DP13 to see if it is safe and effective for people with primary aldosteronism. The study involves 36 patients and aims to find out if DP13 can be a better treatment option for these patients.

Eligible Conditions
  • Conn's syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Aldosterone-to-renin Ratio
Change in Ambulatory Systolic Blood Pressure
Secondary study objectives
Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)
Change in Ambulatory Diastolic Blood Pressure
Change in Potassium
Other study objectives
Change in potassium from baseline
Change in sodium from baseline
Steady state pharmacokinetics

Side effects data

From 2022 Phase 2 trial • 35 Patients • NCT04007406
20%
Headache
10%
Abdominal pain upper
10%
Gastritis
10%
Amylase increase
10%
Blood pressure diastolic increase
10%
Constipation
10%
Lower limb edema
10%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
4 mg DP13
8 mg DP13
12 mg DP13

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: 8 mg DP13 dailyExperimental Treatment1 Intervention
DP13 for 8 weeks
Group II: 4 mg DP13 dailyExperimental Treatment1 Intervention
DP13 for 8 weeks
Group III: 12 mg DP13 dailyExperimental Treatment1 Intervention
DP13 for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dexfadrostat phosphate
2019
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Damian Pharma AGLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Paolo Mulatero, ProfPrincipal InvestigatorUniversity of Torino, Torino, Italy
~6 spots leftby Dec 2025
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