NL-OMON54894CompletedPhase 2
DP13 * A Phase II 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 - DP13C201 study
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- DAMIAN Pharma AG
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Patients will be required to satisfy all of the following eligibility criteria:
- •1. Patients with a guideline-recommended diagnosis of PA consisting of:
- •1.1. ARR *40 derived from a PAC *15 ng/dL and a PRA <1.0 ng/mL/h; an ARR *3.7
- •is derived with PRC <15 mU/L instead of PRA as denominator
- •1.2. PAC >7.0 ng/dL after a 4-hour infusion of 2 litres 0.9% saline (saline
- •load suppression test) or instead if clinically justified for risk of volume
- •expansion ARR>30 and PAC >11 ng/dL (respectively ARR>2.4 with PRC in mU/L
- •instead of PRA as denominator) after 2 hours of an oral intake of 50 mg
- •1.3. determined within <1 year of study enrolment
- •2. Patients with PA per above criteria and
- •2.1. sitting office systolic blood pressure (oSBP) >145 mmHg
- •and if applicable
- •2.2. 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 diltiazem (slow-release 90 - 360 mg
- •daily) or amlodipine (2.5 * 10 mg QD) at adjusted and fixed doses
- •3. Patients with PA per above criteria will have a:
- •3.1. estimated glomerular filtration rate (eGFR) *45 mL/min/1.73 m2 using the
- •MDRD-4 GFR equation: GFR <= 175 x [serum creatinine (mg/dL)]-1.154 x (age)-0.203
- •*f<=1.000 for men; f<=0.742 for women; the formula is further multiplied by
- •factor 1.210 for black skinned patients
- •3.2. body mass index (BMI) between 18 and 34 kg/m2, inclusive
- •3.3. body weight between 40 and 110 kg, inclusive
- •4. Patients with PA per above criteria will be:
- •4.1. female or male patients between 18 and 65 years of age, inclusive
- •4.2. able to provide voluntary informed written consent to study enrolment
Exclusion Criteria
- •Patients will be excluded from the study if they satisfy any of the following
- •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
- •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 diltiazem (slow-release 90 - 360 mg
- •daily) 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
- •3.2. female patients not using intrauterine devices (IUD), diaphragm, sponge
- •with spermicide
- •3.3. male patients not using condoms 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, long QT syndrome, Brugada
- •syndrome, acute heart failure) within 6 months of study enrolment
- •4.2. gastrointestinal tract surgeries or malabsorption syndromes
- •4.3. chronic use of oral or parenteral corticosteroids
- •4.4. use of drugs prolonging the QT interval (e.g., digoxin, sotalol)
- •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 are unable to follow all study procedures
Investigators
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