EUCTR2017-004393-33-ES进行中（未招募）1 期
Multi-center, blinded, randomized, parallel-group, Phase 3 study with aprocitentan in subjects with Resistant Hypertension (RHT) - PRECISIO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 730
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
- •- Screening visit:
- •Signed and dated ICF prior to any study-mandated procedure;
- •Male and female subjects; 18 years (or year of country specific majority) or older;
- •Historical documentation in the subject’s medical records on uncontrolled BP despite at least 3 background antihypertensive
- •medications within 1 year before screening visit;
- •Treated with at least 3 antihypertensive therapies of different pharmacological classes including a diuretic for at least 4 weeks before the screening visit (Visit 1);
- •Mean SiSBP = 140 mmHg measured by AOBPM;
- •Women of childbearing potential are eligible only if the following applies;
- •Negative pregnancy test at screening and at baseline (end of RI period) ;
- •Agreement to undertake pregnancy tests during the study and up to 30 days after randomized study
- •treatment discontinuation;
- •Agreement to use methods of birth control from Screening up to at least 30 days after randomized study
- •treatment discontinuation.
- •- Run-in entry criteria:
- •switched to the standardized;
- •background antihypertensive therapy at least 4 weeks before the first RI visit;
- •Mean trough SiSBP = 140 mmHg measured by AOBPM.
- •- Randomization criteria:
- •Stable dose of the standardized background antihypertensive therapy since the start of the RI period;
- •Mean trough SiSBP = 140 mmHg measured by AOBPM.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •- Apparent/pseudo RHT due to white coat effect, medical inertia, poor therapeutic adherence, or secondary causes of hypertension (except sleep apnea);
- •- Confirmed severe hypertension (grade 3) defined as SiSBP = 180 mmHg and/or SiDBP = 110 mmHg as measured by AOBPM at two different time points.;
- •- Pregnant or lactating subjects;
- •- Clinically significant unstable cardiac disease in the opinion of the investigator;
- •- Severe renal insufficiency;
- •- N-terminal pro-brain natriuretic peptide (NT-proBNP) > or = 200 pg/mL;
- •- Any known factor, disease or clinically relevant medical or surgical conditions that, in the opinion of the investigator, might put the subject at risk, interfere with treatment compliance, study conduct or interpretation of the results
研究者
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