NCT06416865招募中3 期
A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of AJU-C52 in Compared With C52R1M for Essential Hypertension Patients in Inappropriately Controlled on C52R1L Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Changes in MSSBP(mean sitting systolic blood pressure)
研究概览
简要总结
A Randomized, Double-blind, Multi-center, Phase III study to evaluate the efficacy and safety of the AJU-C52 compared with the combination of C52R1M in patients with essential Hypertension Patients who have inappropriately controlled on C52R1L treament
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)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≤19 years.
- •Those who voluntarily signed the informed consent to participate in this study.
- •A patient diagnosed with essential hypertension or Patients taking hypertension medication
- •Those who are eligible for adequate blood pressure criteria during screening tests: Naïve patient-160 mmHg≤MSSBP<200 mmHg and MSDBP<110 mmHg/Patients taking hypertension medication-140 mmHg≤MSSBP<200 mmHg and MSDBP<110 mmHg
排除标准
- •At the screening visit (Visit 1), patients had 3 blood pressure measurements in the arm with the higher average MSSBP, those whose maximum and minimum blood pressure differences are MSSBP 20 mmHg and MSDBP 10 mmHg
- •Secondary hypertension patients or those with a history of suspected secondary hypertension
- •Cardiovascular/cerebrovascular disease
- •Those with a history of malignant tumor within 5 years
研究组 & 干预措施
AJU-C52L, AJU-C52
Experimental
Treatment Period 1: AJU-C52L+C52R1L placebo
Treatment Period 2: AJU-C52+C52R1M placebo
干预措施: AJU-C52L, AJU-C52 (Drug)
C52R1L, C52R1M
Experimental
Treatment Period 1: C52R1L+AJU-C52L placebo
Treatment Period 2: C52R1M+AJU-C52 placebo
干预措施: C52R1L, C52R1M (Drug)
结局指标
主要结局
Changes in MSSBP(mean sitting systolic blood pressure)
时间窗: 8th week
Changes in MSSBP(mean sitting systolic blood pressure) at the 8th week afeter administration of investigational products from the baseline.
次要结局
未报告次要终点
研究者
研究点 (1)
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