A Phase III Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 600
- 试验地点
- 152
研究概览
简要总结
This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years of age
- •Participants with no clinical history of atherosclerotic cardiovascular disease (ASCVD) and a 10-year ASCVD risk estimated as low
- •Participants who have not received any LLT in the 3 months prior to screening
排除标准
- •Asian origin.
- •Statin intolerance
- •Uncontrolled severe hypertension
- •Uncontrolled type 2 diabetes mellitus
- •Inadequately treated hypothyroidism
研究组 & 干预措施
Laroprovstat
The patient will receive a daily dose of Laroprovstat
干预措施: Placebo to match Laroprovstat/Rosuvastatin 2 (Drug)
Placebo
The patient will receive a daily dose of Placebo
干预措施: Placebo to match rosuvastatin (Drug)
Placebo
The patient will receive a daily dose of Placebo
干预措施: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 (Drug)
Placebo
The patient will receive a daily dose of Placebo
干预措施: Placebo to match Laroprovstat/Rosuvastatin 2 (Drug)
Laroprovstat/Rosuvastatin dose combination 1
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
干预措施: Laroprovstat/Rosuvastatin 1 (Drug)
Laroprovstat/Rosuvastatin dose combination 1
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
干预措施: Placebo to match rosuvastatin (Drug)
Laroprovstat/Rosuvastatin dose combination 1
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
干预措施: Placebo to match Laroprovstat/Rosuvastatin 2 (Drug)
Laroprovstat/Rosuvastatin dose combination 2
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
干预措施: Placebo to match rosuvastatin (Drug)
Laroprovstat/Rosuvastatin dose combination 2
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
干预措施: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 (Drug)
Laroprovstat/Rosuvastatin dose combination 2
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
干预措施: Laroprovstat/Rosuvastatin 2 (Drug)
Rosuvastatin dose 1
The patient will receive a daily dose of Rosuvastatin 1
干预措施: Rosuvastatin 1 (Drug)
Rosuvastatin dose 1
The patient will receive a daily dose of Rosuvastatin 1
干预措施: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 (Drug)
Rosuvastatin dose 1
The patient will receive a daily dose of Rosuvastatin 1
干预措施: Placebo to match Laroprovstat/Rosuvastatin 2 (Drug)
Rosuvastatin dose 2
The patient will receive a daily dose of Rosuvastatin 2
干预措施: Rosuvastatin 2 (Drug)
Rosuvastatin dose 2
The patient will receive a daily dose of Rosuvastatin 2
干预措施: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 (Drug)
Rosuvastatin dose 2
The patient will receive a daily dose of Rosuvastatin 2
干预措施: Placebo to match Laroprovstat/Rosuvastatin 2 (Drug)
Laroprovstat
The patient will receive a daily dose of Laroprovstat
干预措施: Laroprovstat (Drug)
Laroprovstat
The patient will receive a daily dose of Laroprovstat
干预措施: Placebo to match rosuvastatin (Drug)