NL-OMON52196已完成2 期
A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants with Hyperlipidaemia (SOLANO) - SOLANO
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Astra Zeneca
- 入组人数
- 26
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Participant must be 18 to 75 years of age, inclusive, at the time of signing
- •the informed consent
- •- Participants who have a fasting LDL-C >= 70 mg/dL (1.8 mmol/L) but < 190 mg/dL
- •(4.9 mmol/L) at screening
- •- Participants who have fasting triglycerides < 400 mg/dL (< 4.52 mmol/L) at
- •- Participants are receiving a stable dose (>= 3 months) of maximally tolerated
- •statin and/or ezetimibe therapy at screening
- •- Male or female of non-childbearing potential
- •- Signed and dated written informed consent prior to any mandatory study
- •specific procedures, sampling, and analyses
排除标准
- •- eGFR < 40 mL/min/1.73m2 using the CKD-EPI
- •- History or presence of gastrointestinal, hepatic or renal disease or any
- •other conditions known to interfere with absorption, distribution, metabolism
- •or excretion of drugs
- •- Any uncontrolled or serious disease, or any medical (eg,. known major active
- •infection or major haematological, renal, metabolic, gastrointestinal or
- •endocrine dysfunction) or surgical condition that, in the opinion of the
- •investigator, may either interfere with participation in
- •the clinical study and/or put the participant at significant risk (according to
- •the investigator's judgment) if he/she participates in the clinical study
- •- Poorly controlled T2DM, defined as HbA1c > 10%
- •- Acute ischaemic cardiovascular events including stroke within 30 days, or
- •heart failure with New York Heart Association (NYHA) Class III to IV
- •- Blood dyscrasias with increased risk of bleeding including idiopathic
- •thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of
- •increased risk of bleeding (frequent bleeding gums or nose bleeds)
- •- High-risk of bleeding diathesis or anti-platelet therapy other than low dose
- •aspirin (<=100mg/day).
- •- Malignancy within the last 10 years
- •- Recipient of any major organ transplant
- •- LDL or plasma apheresis within 12 months prior to randomisation
- •- Uncontrolled hypertension defined as average supine SBP > 160 mmHg or DBP >
- •- Heart rate after 10 minutes supine rest < 50 or > 100 bpm
- •- Any laboratory values with the following deviations at the Screening Visit;
- •test may be repeated at the discretion of the investigator if abnormal:
- •Any positive result on screening for serum hepatitis B surface antigen,
- •hepatitis C antibody, and human immunodeficiency virus (HIV)
- •ALT > 1.5 × ULN
- •AST > 1.5 × ULN
- •TBL > ULN
- •ALP > 1.5 × ULN
- •WBC < lower limit of normal (LLN).
- •Haemoglobin < 12 g/dL in males or < 11 g/dL in females
- •Platelet count <= LLN
- •aPTT > ULN or Prothrombin Time > ULN
- •UACR > 11 mg/mmol (100 mg/g)
- •UPCR > 300 mg/g
- •-Any clinically important abnormalities in rhythm, conduction or morphology of
- •the resting ECG and any clinically important abnormalities in the 12-lead ECG
- •-QTcF > 470 ms; high degree atrioventricular (AV)-block grade II-III and sinus
- •node dysfunction with significant sinus pause untreated with pacemaker; and
- •cardiac tachyarrhythmias
- •- History of drug and/or alcohol abuse or a positive screen for drugs of abuse
- •- use of warfarin, direct or indirect thrombin inhibitors or factor Xa
- •- Mipomersen, or lomitapide within 12 months prior to randomisation
- •- Any fibrate therapy other than fenofibrate; if the participant is on
- •fenofibrate therapy, the dose should be stable for at least 6 weeks prior to
- •randomisation
- •- Previous administration of AZD8233/AZD6615) or inclisiran (LEQVIO ® Novartis)
- •- Use of evolocumab (REPATHA® Amgen) and alirocumab (PRALUENT® Regeneron)
- 另有 1 项未显示
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