NCT05385770已完成3 期
A Multicentre, Randomized, Double-blind Study to Evaluate and Compare the Efficacy and Safety of 8-week Treatment With AZM and AML Combined and Alone in Mild-to-moderate Essential Hypertensive Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 890
- 试验地点
- 1
- 主要终点
- msitSBP
研究概览
简要总结
This is an 8-week, randomized, double-blind Phase 3, multicentre study to determine the optimal dose of AZM and AML in combination therapy and to compare efficacy and tolerability of the combined therapy to each of the monotherapy in essential hypertensive subjects who are not adequately controlled on AZM and AML monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Single-blind Run-in period, Double-blind Treatment period
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily agree to participate in the trial and signed the written ICF, after listening to the purpose, method, and effect of clinical trial
- •Male or female adult subjects (Legal minimum age of adult requirement is country specific, and requirement of current country specific regulations will be applied) below the age of 75 years, inclusive
- •Subjects with mild-to-moderate essential hypertension
- •Subjects who are capable of understanding and complying with protocol requirements
排除标准
- •Subjects who have msitSBP >180 mmHg or msitDBP >110 mmHg; Subjects who have difference in the blood pressure between 3 measurements (confirmed by a second set of three measurements; 3 sitting systolic BP (sitSBP) measurements differing by more than 20 mmHg or 3 sitting diastolic BP (sitDBP) measurements differing by more than 10 mmHg)
- •Secondary hypertension, Symptomatic orthostatic hypotension
- •Clinically significant Electrocardiogram (ECG) abnormalities, Severe heart disease, Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia, Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
- •Severe cerebrovascular disease, Known moderate or malignant retinopathy within the past 6 months; History of unexplained syncope within the prior 2 years, or a known syncopal disorder
- •Significant thyroid disease, Type 1 or 2 diabetes mellitus with poor glucose control, Wasting disease, Autoimmune diseases, Connective tissue disease
- •Subjects who have clinically significant laboratory abnormalities : creatinine clearance < 30 mL/min, serum creatinine > 2 mg/dL or > 200 μmol/L, serum potassium <3.5 mmol/L or > 5.5mmol/L, alanine aminotransferase or aspartate aminotransferase > 3 × upper limit normal (ULN)
- •Any surgical or medical condition of the gastrointestinal tract that might significantly alter the absorption, distribution, metabolism, or excretion of the drug
- •Positive for HIV, HCV Ab, and/or HBsAg
- •History of drug or alcohol abuse within the past 1 year
- •Subjects who are pregnant or lactating women, women suspected of being pregnant, women who wish to be pregnant during the study, or women of child-bearing potential who are not using medically acceptable methods of contraception
- •Any chronic inflammatory condition needing chronic anti-inflammatory therapy, A known hypersensitivity to any main excipients and components of the investigational drugs or other drugs in the same class, Subjects who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-converting enzyme inhibitors or angiotensin II subtype 1 receptor blocker
- •Subjects who have received any investigational product within 28 days prior to screening or is currently participating in another investigational study
- •Subjects who are required to take excluded medications at any point during the study
研究组 & 干预措施
AZM Xmg
Active Comparator
1. AZM Xmg (4 weeks) Non-responder -> AZM Xmg (8 weeks)
干预措施: AZM X mg (Drug)
AZM X'mg
Active Comparator
1. AZM X'mg (4 weeks) Non-responder -> AZM X'mg (8 weeks)
干预措施: AZM X' mg (Drug)
AML Ymg
Active Comparator
1. AML Ymg (4 weeks) Non-responder -> AML Ymg (8 weeks)
干预措施: AML Y mg (Drug)
AML Y'mg
Active Comparator
1. AML Y'mg (4 weeks) Non-responder -> AML Y'mg (8 weeks)
干预措施: AML Y' mg (Drug)
AZM/AML X/Ymg
Active Comparator
- AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)
- AML Ymg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)
干预措施: AZM X mg + AML Y mg (Drug)
AZM/AML X/Ymg
Active Comparator
- AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)
- AML Ymg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)
干预措施: AZM X mg (Drug)
AZM/AML X/Ymg
Active Comparator
- AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)
- AML Ymg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)
干预措施: AML Y mg (Drug)
AZM/AML X'/Ymg
Active Comparator
- AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)
- AML Ymg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)
干预措施: AZM X' mg + AML Y mg (Drug)
AZM/AML X'/Ymg
Active Comparator
- AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)
- AML Ymg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)
干预措施: AZM X' mg (Drug)
AZM/AML X'/Ymg
Active Comparator
- AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)
- AML Ymg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)
干预措施: AML Y mg (Drug)
AZM/AML X/Y'mg
Active Comparator
- AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)
- AML Y'mg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)
干预措施: AZM X mg + AML Y' mg (Drug)
AZM/AML X/Y'mg
Active Comparator
- AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)
- AML Y'mg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)
干预措施: AZM X mg (Drug)
AZM/AML X/Y'mg
Active Comparator
- AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)
- AML Y'mg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)
干预措施: AML Y' mg (Drug)
AZM/AML X'/Y'mg
Active Comparator
- AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)
- AML Y'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)
干预措施: AZM X' mg + AML Y' mg (Drug)
AZM/AML X'/Y'mg
Active Comparator
- AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)
- AML Y'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)
干预措施: AZM X' mg (Drug)
AZM/AML X'/Y'mg
Active Comparator
- AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)
- AML Y'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)
干预措施: AML Y' mg (Drug)
结局指标
主要结局
msitSBP
时间窗: after 8 weeks of treatment
msitSBP change from baseline
次要结局
- msitDBP(after 4 weeks of treatment)
- msitSBP(after 4 weeks of treatment)
- Proportion of subjects achieving msitSBP < 140 mmHg and/or ΔmsitSBP ≥ 20 mmHg(after 4, 8 weeks of treatment)
- Proportion of subjects achieving msitDBP < 90 mmHg and/or ΔmsitDBP ≥ 10 mmHg(after 4, 8 weeks of treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study of CM310 Injection in Adolescent Subjects With Atopic DermatisAtopic DermatitisNCT06277765Keymed Biosciences Co.Ltd180
已完成
3 期
A Study of CM310 in Patients With Moderate-to-Severe Atopic DermatitisAtopic DermatitisNCT05265923Keymed Biosciences Co.Ltd500
已完成
3 期
A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated PainEndometriosisNCT06076486Nanjing Chia-tai Tianqing Pharmaceutical202
招募中
3 期
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLCNon-small Cell Lung CancerNCT061237543D Medicines (Sichuan) Co., Ltd.390
终止
3 期
The Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in the Treatment of Major Depressive DisorderMajor Depressive DisorderNCT03487198Otsuka Beijing Research Institute65