Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a multicenter randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bempedoic Acid Tablet | Experimental | Bempedoic Acid Tablet Once daily, oral |
|
| Placebo | Placebo Comparator | Placebo Once daily, oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bempedoic Acid Tablet | Drug | bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in LDL-C levels at Week 12 | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving LDL-C target | Baseline, Week 12 | |
| Percentage change from baseline in non-HDL-C、ApoB、TC、hs-CRP levels at Week 12 | Baseline, Week 12 | |
Not provided
Inclusion Criteria:
1. 18 years and older. 2. 18.5 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2. 3. Diagnosis with ASCVD or have high-risk ASCVD, and/or diagnosis with HeFH.4.Be on stable lipid-modifying therapy for at least 4 weeks prior to screening, including moderate to high-dose statins with or without other lipid-modifying therapy (cholesterol absorption inhibitors[ezetimibe, Hyzetimibe],fibrates [except gemfibrozil]); 5.Fasting LDL-C must meet any one of the following
6.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy |
|
| Adverse events (AEs) and serious adverse events (SAEs) during the study |
| Baseline, Week 13 |