NCT06121518已完成3 期
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure))
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients
详细描述
This study is a Randomized, Double-blind, Multi-center, Therapeutic confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients
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)
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
- •Subjects who are 19 years old or older.
- •Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:
- •Didn't take antihypertensive drug
- •140 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg
- •Taking antihypertensive drug
- •130 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg
- •Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.
排除标准
- •Subjects with a history of secondary hypertension or suspected secondary hypertension
- •Subjects with symptomatic orthostatic hypotension
- •Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c > 9.0%)
- •Subjects with Severe heart failure(NYHA Class 3,4) etc.,
- •Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening
- •Subjects with a history of disability to investigational product ADME at the time of screening
- •Subjects with abnormalities in laboratory test results at the time of screening
- •Subjects with hypersensitivity or history of investigational product and similar drugs
- •Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
- •Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
- •Subjects who received other investigational product within 4 weeks of screening visit
- •Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last investigational product
- •Subjects who are unable to participate in this clinical trial at the discretion of the investigator
研究组 & 干预措施
Experimental Group
Experimental
D064 and D702 Combination Therapy
干预措施: D064 and D702, QD (Drug)
Comparator Group 1
Active Comparator
D064 Monotherapy
干预措施: D064 and Placebo of D702, QD (Drug)
Comparator Group 2
Active Comparator
D702 Monotherapy
干预措施: Placebo of D064 and D702, QD (Drug)
结局指标
主要结局
Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure))
时间窗: 8 weeks
Compare experimental group with comparator group
次要结局
未报告次要终点
研究者
研究点 (1)
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