A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on LDL-C in LLT-naïve Patients
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
The purpose of this study is to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients with hypercholesterolaemia. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：AstraZeneca Clinical Study Information Center
- 电话号码：9479 +1877240
- 邮箱：information.center@astrazeneca.com
学习地点
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Beijing、中国、102218
- Research Site
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Chifeng、中国、024000
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Guangzhou、中国、510220
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Hangzhou、中国、310009
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Ha’erbin、中国、150001
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Hefei、中国、230601
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Liuzhou、中国、545006
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Luoyang、中国、471003
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Nanchang、中国、330009
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Nanjing、中国、210011
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Sanya、中国、572000
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Shanghai、中国、200032
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Shantou、中国、515065
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Shiyan、中国、442099
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Suining、中国、629000
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Tangshan、中国、63000
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Tianjin、中国、300000
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Yueyang、中国、414000
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Zhengzhou、中国、450000
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Zigong、中国、643000
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Bangkok、泰国、10700
- Research Site
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Banphaeo、泰国、74120
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Chiang Mai、泰国、50200
- Research Site
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Phutthamonthon、泰国、73170
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Ratchathewi、泰国、10400
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Haiphong、越南、180000
- Research Site
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Ho Chi Minh City、越南、700000
- Research Site
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Hochiminh、越南、700000
- Research Site
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Hochiminh City、越南、700000
- Research Site
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Hà Nội、越南、100000
- Research Site
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Daegu、韩国、42601
- Research Site
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Seoul、韩国、134-727
- Research Site
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Seoul、韩国、143-729
- Research Site
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Wŏnju、韩国、26426
- Research Site
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Hong Kong、香港
- Research Site
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Hong Kong、香港、00000
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Hong Kong、香港、999077
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Ampang、马来西亚、68000
- Research Site
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Beseri、马来西亚、02400
- Research Site
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Kuala Kedah、马来西亚、06600
- Research Site
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Puchong、马来西亚、47100
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Sarawak Miri、马来西亚、98000
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participant must be ≥ 18 years of age
- Participants with no clinical history of ASCVD and a 10-year ASCVD risk estimated as low
- Participants who have not received any LLT in the 3 months prior to screening
- Participants of Asian origin.
Exclusion Criteria:
- Statin intolerance
- Uncontrolled severe hypertension
- Uncontrolled type 2 diabetes mellitus
- Inadequately treated hypothyroidism
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Laroprovstat
The patient will receive a daily dose of Laroprovstat. |
daily oral dose of the Laroprovstat daily oral dose of the Placebo to match Rosuvastatin |
|
有源比较器：Rosuvastatin Dose 1
The patient will receive a daily dose of Rosuvastatin 1. |
daily oral dose of the Rosuvastatin 1
其他名称：
daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin |
|
有源比较器：Rosuvastatin Dose 2
The patient will receive a daily dose of Rosuvastatin 2. |
daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin daily oral dose of the Rosuvastatin 2 |
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实验性的：FDC laroprovstat/rosuvastatin Dose combination 1
The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 1. |
daily oral dose of the Placebo to match Rosuvastatin daily oral dose of the FDC Laroprovstat/Rosuvastatin 1 |
|
实验性的：FDC laroprovstat/rosuvastatin Dose combination 2
The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 2. |
daily oral dose of the Placebo to match Rosuvastatin daily oral dose of the FDC Laroprovstat/Rosuvastatin 2 |
|
安慰剂比较：Placebo
The patient will receive a daily dose of Placebo. |
daily oral dose of the Placebo to match Rosuvastatin daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Relative change in LDL-C
大体时间：Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin Dose 2 versus placebo, rosuvastatin Dose 2, and laroprovstat on LDL-C at Week 8. |
Week 8
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Relative change in LDL-C
大体时间：Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin Dose 1 versus placebo, rosuvastatin Dose 1, and laroprovstat on LDL-C at Week 8. |
Week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Relative change in Apo B
大体时间：Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on Apo B at Week 8. |
Week 8
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Relative change in non-HDL-C
大体时间：Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-HDL-C at Week 8. |
Week 8
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Relative change in total cholesterol
大体时间：Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at Week 8. |
Week 8
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- D7961C00006
计划个人参与者数据 (IPD)
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IPD 计划说明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共享时间框架
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共享访问标准
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 共享支持信息类型
- 研究方案
- 树液
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