JPRN-jRCT2051210041
Active, not recruiting
Phase 1
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 sites91 target enrollmentJune 23, 2021
ConditionsDyslipidemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dyslipidemia
- Sponsor
- Hibi Kazushige
- Enrollment
- 91
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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\)
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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