A Multicenter, Randomized, Double-Blind, Parallel, Phase 2(2b) Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8.
研究概览
简要总结
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Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Additionally, it seeks to confirm the contribution of each component at low doses.
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Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
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Exclusion Criteria: Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
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Methods: This study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration.
Screening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. These participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.
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
- Double (Participant, Investigator)
盲法说明
Double-Blinded
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
- •Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
排除标准
- •Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
研究组 & 干预措施
SPC 1001 Mid2
干预措施: SPC 1001 Mid2 (Drug)
SPC2002
干预措施: SPC 1001 Mid2 (Drug)
SPC2002
干预措施: SPC 2002 (Drug)
SPC2003
干预措施: SPC 1001 Mid2 (Drug)
SPC2003
干预措施: SPC 2003 (Drug)
SPC2004
干预措施: SPC 1001 Mid2 (Drug)
SPC2004
干预措施: SPC 2004 (Drug)
结局指标
主要结局
The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8.
时间窗: Change from Baseline in MSSBP at Week 8
次要结局
未报告次要终点