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临床试验/2026-526258-15-00
2026-526258-15-00招募中3 期

A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared with Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients with Hypercholesterolaemia.

AstraZeneca AB9 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年9月15日最近更新:
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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
60
试验地点
9
主要终点
Relative change in LDL‑C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8weeks
研究概览入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks

入排标准

年龄范围
18 years 至 65+ years（18-64 Years, 65+ Years）
接受健康志愿者
否

入选标准

  • •Participant must be ≥ 18 years of age
  • •Participants must be on a stable dose of all background LLTs
  • •The stable statin dose should be judged as their maximally tolerated dose
  • •Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event

排除标准

  • •Asian origin
  • •Uncontrolled severe hypertension
  • •Uncontrolled T2DM
  • •Inadequately treated hypothyroidism

研究组 & 干预措施

Crestor (rosuvastatin) encapsulated tablet, Crestor (rosuvastatin) encapsulated tablet, Crestor (rosuvastatin) encapsulated tablet, Crestor (rosuvastatin) encapsulated tablet

Comparator

干预措施: Crestor (rosuvastatin) encapsulated tablet (Drug)

Laroprovstat/Rosuvastatin FDC, Laroprovstat/Rosuvastatin FDC, Laroprovstat/Rosuvastatin FDC, Laroprovstat/Rosuvastatin FDC

Test

干预措施: Laroprovstat/Rosuvastatin FDC (Drug)

结局指标

主要结局

Relative change in LDL‑C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8weeks

Relative change in LDL‑C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8weeks

次要结局

  • Relative change in Apo B at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks
  • Relative change in non‑HDL‑C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks
  • Relative change in total cholesterol at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks

研究者

申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

AstraZeneca Clinical Study Information Centre

Scientific

AstraZeneca AB

研究点 (9)

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