EUCTR2019-000919-85-IT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
- •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
排除标准
- •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
- •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
研究者
相似试验
进行中（未招募）
1 期
Study in Patients with Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of the Aldosterone Synthase Inhibitor, DP13, over an 8-week Treatment PeriodPrimary AldosteronismEUCTR2019-000919-85-NLDAMIAN Pharma AG36
已完成
2 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 PeriodHormonal diseasesPrimary AldosteronismNL-OMON54894DAMIAN Pharma AG15
未知
2 期
A M117101 phase II study in patients with primary palmar hyperhidrosisprimary palmar hyperhidrosisJPRN-jRCT2080222374Maruho Co.,Ltd.
招募中
2 期
A Phase 2 Study of ADR-001 in Patients with Severe Pneumonia caused by SARS-CoV-2 infectioPatients with Severe Pneumonia caused by SARS-CoV-2 infectionJPRN-jRCT2053210023Okawa Sumito20
进行中（未招募）
2 期
ADR-001-N1Compensated liver cirrhosis (Child-Pugh A)JPRN-jRCT2033210425Terai Shuji9