NCT05526703招募中3 期
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy
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
- 108
- 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 D701 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 who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
- •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, D701, placebo of D012 (Drug)
Comparator Group
Active Comparator
干预措施: D012, placebo of D064, placebo of D701 (Drug)
结局指标
主要结局
Change from baseline in MSSBP
时间窗: 8 weeks after drug administrations
Compare experimental group with comparator group
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination TherapyEssential HypertensionNCT05931224Chong Kun Dang Pharmaceutical346
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
3 期
A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive BladderOveractive BladderNCT00685113Duramed Research1,104
已完成
3 期
The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients with Type 2 DiabetesType 2 DiabetesNCT05566028Chong Kun Dang Pharmaceutical172