AT1R x NCC x VDCCs

- 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.
- Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
- 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.
- 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.

以二复方奥美沙坦酯/氢氯噻嗪片为对照，评价三复方奥美沙坦酯/氨氯地平/氢氯噻嗪片治疗原发性高血压患者的疗效和安全性。主要终点为随机分组至双盲治疗期8周结束，平均坐位舒张压（msDBP）的变化。次要终点为从随机分组至双盲治疗期8周结束，平均坐位收缩压（msSBP）的变化；从随机分组至双盲治疗期4 周结束，msDBP 和msSBP 的变化；双盲治疗期第4和8周结束，达到目标血压的受试者[msSBP/msDBP<140/90 mmHg 或糖尿病、慢性肾脏病患者（肌酐清除率≥30 mL/min 和≤60 mL/min）msSBP/msDBP< 130/80 mmHg]百分比。