A Randomized, Active-controlled, Double-blind, Parallel, Multi Center, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated ATB-1011 and ATB-1012 in Patients With Essential Hypertension and Type II Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012)
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of ATB-1011 and ATB-1012 co-administration in patients with essential hypertension and type II diabetes mellitus
详细描述
Primary Objectives:
- To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in blood pressure control over ATB-1012 monotherapy
- To demonstrate superiority of 12-week co-administration of ATB-1011 and ATB-1012 in diabetes control over ATB-1011 monotherapy
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
- •Those with Primary Hypertension and Type II Diabetes Mellitus (DM)
- •Those who have been given adequate explanation about the purpose and the details of the clinical trial and have given voluntary, written informed consent
- •Those who have not taken any antihypertensive agents for ≥2 weeks prior to randomization.
- •Those who have not taken any oral hypoglycemic agents, except for same dose of metformin (≥1000 mg/day), for ≥8 weeks prior to randomization
排除标准
- •Those with reference arm mean sitting diastolic blood pressure (MSDBP) ≥110 mmHg at screening or at randomization
- •Those with differences of systolic blood pressure (SBP) ≥ 20 mmHg and diastolic blood pressure (DBP) ≥ 10 mmHg between arms measured 3 consecutive times with ≥2 minutes between each measurement at screening
- •Those with a history of alcohol or substance abuse
- •Those who are pregnant or nursing
- •Those who have received other clinical trial drugs within 12 weeks prior to screening
- •Those who are deemed ineligible to participate in the clinical trial based on the medical opinion of the investigator
研究组 & 干预措施
ATB-1011
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1013 placebo (Drug)
ATB-1011 + ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1011 (Drug)
ATB-1011 + ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1012 (Drug)
ATB-1011 + ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1013 placebo (Drug)
ATB-1012 + ATB-1013
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1012 (Drug)
ATB-1012 + ATB-1013
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1013 (Drug)
ATB-1012 + ATB-1013
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1011 placebo (Drug)
ATB-1011
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1011 (Drug)
ATB-1011
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1012 placebo (Drug)
ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1012 (Drug)
ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1011 placebo (Drug)
ATB-1012
Participants will receive 1 tablet/day of each drug for 12 weeks
干预措施: ATB-1013 placebo (Drug)
结局指标
主要结局
Mean sitting systolic blood pressure (MSSBP) (ATB-1011+ATB-1012 vs. ATB-1012)
时间窗: baseline to Week 12
Change in MSSBP with ATB-1011 + ATB-1012 co-administration compared to ATB-1012 monotherapy
Hemoglobin A1c (HbA1c) (ATB-1011+ATB-1012 vs. ATB-1011)
时间窗: baseline to Week 12
Changes in HbA1c with ATB-1011 + ATB-1012 co-administration compared to ATB-1011 monotherapy
次要结局
- MSSBP (ATB-1012+ATB-1013 vs. ATB-1012)(baseline to Week 12)
- MSSBP (ATB-1012+ATB-1013 vs ATB-1011+ATB-1012)(baseline to Week 12)
- HbA1c (ATB-1011+ATB-1012 vs. ATB-1012)(baseline to Week 12)
- Changes in MSSBP(baseline to Weeks 4 and 8)
- Changes in mean sitting diastolic blood pressure (MSDBP)(baseline to Weeks 4, 8, and 12)
- MSSBP (ATB-1011+ATB-1012 vs. ATB-1011)(baseline to Week 12)
- Changes in glycemic parameters(baseline to Weeks 4, 8, and 12)
- Changes in HbA1c(baseline to Weeks 4, 8, and 12)