EUCTR2017-004393-33-PL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
- 600
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 criteria:
- •- 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 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
- •-- Negative pregnancy test at screening and at baseline (i.e., end of RI
- •-- 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
- •for at least 1 week before Day -1 (end 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 at screening or in the
- •past in the opinion of the investigator, e.g. uncontrolled symptomatic
- •arrhythmia, atrial fibrillation, congestive heart failure NYHA stage II
- •with relevant mitral valve insufficiency and/or aortic stenosis,
- •congestive heart failure NYHA stage III or IV;
- •- Severe renal insufficiency;
- •- N-terminal pro-brain natriuretic peptide (NT-proBNP) = 500 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
- •- Treatment with any medication which may affect blood pressure
- •and/or treatment with high dose of loop diuretics (i.e., furosemide
- •greater than 80 mg/day, or equivalent dosage of other loop diuretics).
研究者
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