JPRN-jRCT2051210041进行中（未招募）1 期
A Phase 1 and 2 Study of AZD8233 in Participants with Dyslipidemia and this study consists of Part A, Part B and Part C. Part A is designed as a randomized, single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study. Part B is designed as a randomized, double-blind, placebo-controlled, dose-ranging, phase 2 study. . Part C is designed as a randomized , single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study. - HAYATE
Hibi Kazushige0 个研究点目标入组 91 人开始时间: 2021年6月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •- Participants must be 20 to 60 years of age inclusive, at the time of signing the informed consent
- •- Participants who have a fasting LDL-C 70 mg/dLor more but < 140 mg/dL at screening
- •- Participants who have fasting triglycerides < 400 mg/dL at screening
- •- Participants who should be receiving statin therapy
- •- Participants who should be on stable medication for a certain time period prior to randomization
- •- Body mass index (BMI) between 19 and 40 kg/m2
- •- Females must not be pregnant and must have a negative pregnancy test at screening and randomisation, must not be lactating , and must be of nonchild-bearing potential
- •- Participants must be 20 to 75 years of age inclusive, at the time of signing the informed consent
- •- Have a fasting LDL-C 70 mg/dL or more but < 190 mg/dL at screening (Visit 2)
- •- Have fasting triglycerides < 400 mg/dL at screening (Visit 2)
- •- Should be receiving statin therapy
- •- LDL-lowering medications should be on stable dosing for 3 months prior or more to screening with no planned medication or dose change during study participation
- •- BMI between 19 and 40 kg/m2
- •- Female participants must not be pregnant and must have a negative pregnancy test at screening and randomisation, must not be lactating, and must not be of childbearing potential
- •- Participants must be 20 to 60 years of age inclusive, at the time of signing the informed consent
- •- Participants who have a fasting LDL-C 70 mg/dL or more but < 140 mg/dL at screening
- •- Participants who have fasting triglycerides < 400 mg/dL at screening
- •- Participants who should be receiving statin therapy
- •- Participants who should be on stable medication for a certain time period prior to randomization
- •- Body mass index (BMI) between 19 and 40 kg/m2
- •- Females must not be pregnant and must have a negative pregnancy test at screening and randomization, must not be lactating, and must be of nonchild-bearing potential
排除标准
- •- eGFR < 60 mL/min/1.73m2 using the Japanese equation
- •- Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding. Or participants receiving anti-coagulation therapy
- •- History of major bleed or high-risk of bleeding diathesis
- •- Subjects with a high 10-year risk of coronary heart disease as calculated using the Suita score
- •- Heart rate after 10 minutes of sitting rest < 50 or > 100 beats per minute
- •- Uncontrolled hypertension defined as sitting SBP > 140 mmHg or DBP > 90 mmHg
- •- eGFR < 40 mL/min/1.73m2 using the Japanese equation at Visit 1
- •- Poorly controlled type 2 diabetes mellitus (T2DM), defined as Haemoglobin A1c (HbA1c) > 10% at Visit 1
- •- Acute ischaemic cardiovascular event in the last 12 months prior to randomization
- •- Heart failure with New York Heart Association (NYHA) Class III-IV
- •- High-risk of bleeding diathesis as judged by the Investigator
- •- Uncontrolled hypertension defined as sitting SBP > 160 mmHg or DBP > 90 mmHg at Visit 1 or Visit 3
- •- Heart rate after 10 minutes sitting rest < 50 bpm or > 100 bpm at Visit 1 or Visit 3
- •- eGFR < 60 mL/min/1.73m2 using the Japanese equation
- •- Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding. Or participants receiving anti-coagulation therapy
- •- History of major bleed or high-risk of bleeding diathesis
- •- Subjects with a high 10-year risk of coronary heart disease as calculated using the Suita score
- •- Heart rate after 10 minutes of sitting rest < 50 or > 100 beats per minute
- •- Uncontrolled hypertension defined as sitting SBP > 140 mmHg or DBP > 90 mmHg
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