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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
Study 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.
Eligible Conditions
- Conn Syndrome
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in aldosterone
Change in ambulatory blood pressure
Secondary outcome measures
Change in blood pressure
Occurrence of adverse events
Other outcome measures
Change in potassium from baseline
Change in sodium from baseline
Steady state pharmacokinetics
Trial Design
3Treatment groups
Experimental Treatment
Group I: DP13 middleExperimental Treatment1 Intervention
DP13 for 8 weeks
Group II: DP13 lowExperimental Treatment1 Intervention
DP13 for 8 weeks
Group III: DP13 highExperimental Treatment1 Intervention
DP13 for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DP13
2017
Completed Phase 2
~90
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Who is running the clinical trial?
Damian Pharma AGLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
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