Study in Patients with Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of the Aldosterone Synthase Inhibitor, DP13, over an 8-week Treatment Period

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 36

Inclusion Criteria

• ARR of =40 with plasma aldosterone concentration (PAC) =15 ng/dL and plasma renin activity (PRA) <1.0 ng/mL/h. A prescreening ARR of =3.7 results by using plasma renin concentration (PRC) <15 mU/L instead of PRA as denominator.
• A IV saline loading test (2 litres of 0.9% saline infused over 4 hours) with resulting PAC >7.0 ng/dL after infusion. For patients at risk for volume expansion, a captopril test (50 mg captopril peroral) can be used instead with resulting ARR >30 and PAC >11 ng/dL (respectively ARR >2.4 using PRC in mU/L instead of PRA as denominator).
• Systolic blood pressure >145 mmHg by automatic office blood pressure measurement and in presence of hypertension control therapy (doxazosin 1 - 8 mg QD and, only if necessary, verapamil slow release 40 - 120 mg BID or amlodipine 2.5 - 10 mg QD).
•Estimated glomerular filtration rate (eGFR) =45 mL/min/1.73 m2 using the MDRD-4 GFR equation

Formal eligibility verification after implementation of a doseadjusted blood pressure control therapy with a documented case review process led by the Central Review Board is mandatory prior to final enrolment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

Patients will be excluded from the study if they satisfy any of the following criteria:
1. Patients with PA and:
1.1. treated with spironolactone within 2 months of enrolment
1.2. hyperkalaemia of >5.0 mmol/L
1.3. prolonged QT intervals with QTc of >500 msec using Bazett’s formula

2. Patients with PA and:
2.1. sitting office systolic office blood pressure (oSBP) >190 mmHg
and/or
2.2. sitting office diastolic office blood pressure (oDBP) >110 mmHg
and if applicable
2.3. in presence of non-interfering hypertension control therapy consisting of doxazosin (1
– 8 mg QD) as first-line medication and, if necessary, only verapamil slow release (40
– 120 mg BID) or amlodipine (2.5 – 10 mg QD) at adjusted and fixed doses

3. Patients with PA who will not consent to special contraception measures during the entire
study period, specifically
3.1. female patients not withdrawing oral contraceptives >2 weeks prior to enrolment
3.2. female patients not using intrauterine devices (IUD), diaphragm, sponge with
spermicide or adhering to abstinence
3.3. male patients not using condoms or not adhering to abstinence and not refraining from
sperm donation

4. Patients with PA and a medical history of:
4.1. cerebro- and cardiovascular events (stroke, myocardial infarction, percutaneous
transluminal coronary angioplasty) within 6 months of study enrolment
4.2. gastrointestinal tract surgeries or malabsorption syndromes
4.3. chronic use of oral or parenteral corticosteroids

5. Patients with PA who:
5.1. participated in any clinical study within 6 weeks
5.2. suffered a significant blood loss within <2 months
5.3. had a significant illness within <2 weeks
5.4. are pregnant or breastfeeding
5.5. are unable to follow all study procedures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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