EUCTR2019-000919-85-NL进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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 and
- •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 captopril and
- •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 = 1.75 x [serum creatinine (mg/dL)]-1.154 x (age)-0.203 x f*
- •*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
- •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
排除标准
- •-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 enrolment
- •3.2. female patients not using intrauterine devices (IUD), diaphragm, or 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
- •5.5. are unable to follow all study procedures
研究者
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