NCT05931224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 D660 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
- 346
- 试验地点
- 1
- 主要终点
- Change from baseline in MSSBP
研究概览
简要总结
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy
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 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 hypersensitivity or history of clinical trial drugs 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 clinical trial drugs 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 clinical trial drug
- •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
干预措施: D064, D702, placebo of D660 (Drug)
Comparator Group
Experimental
干预措施: D660, placebo of D064, placebo of D702 (Drug)
结局指标
主要结局
Change from baseline in MSSBP
时间窗: 8 weeks after drug administrations
MSSBP(Mean Sitting Systolic Blood Pressure)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination TherapyEssential HypertensionNCT05526703Chong Kun Dang Pharmaceutical108
已完成
3 期
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 MonotherapyEssential HypertensionNCT06121518Chong Kun Dang Pharmaceutical235
已完成
4 期
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity StatinCardiovascular DiseasesNCT04080310Seoul National University Bundang Hospital270
已完成
2 期
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT03662542Janssen Research & Development, LLC214
已完成
2 期
Phase II Study of Best Support Care (BSC) Plus ZD6474(Vandetanib) in Patients With Inoperable Hepatocellular Carcinoma (HCC)Carcinoma, HepatocellularNCT00508001Genzyme, a Sanofi Company67