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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526258-15-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laroprovstat/rosuvastatin dose 1 | Experimental | Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1 |
|
| rosuvastatin dose 1 | Active Comparator | Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1 |
|
| laroprovstat/rosuvastatin dose 2 | Experimental | Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2 |
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| rosuvastatin dose 2 | Active Comparator | Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2 |
|
| laroprovstat/rosuvastatin dose 3 | Experimental | Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laroprovstat/rosuvastatin 1 | Combination Product | daily oral dose of the laroprovstat/rosuvastatin 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in LDL-C at 8 weeks | To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
| Relative change in non-HDL-C at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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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.
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.
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
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| rosuvastatin dose 3 | Active Comparator | Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3 |
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| laroprovstat/rosuvastatin dose 4 | Experimental | Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4 |
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| rosuvastatin dose 4 | Active Comparator | Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4 |
|
| laroprovstat/rosuvastatin 2 | Combination Product | daily oral dose of the laroprovstat/rosuvastatin 2 |
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| laroprovstat/rosuvastatin 3 | Combination Product | daily oral dose of the laroprovstat/rosuvastatin 3 |
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| laroprovstat/rosuvastatin 4 | Combination Product | daily oral dose of the laroprovstat/rosuvastatin 4 |
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| Placebo to match laroprovstat/rosuvastatin 1,2,3 | Drug | Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3 |
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| Placebo to match laroprovstat/rosuvastatin 4 | Drug | Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4 |
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| Rosuvastatin 1 | Drug | daily oral dose of rosuvastatin 1 |
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| Rosuvastatin 2 | Drug | daily oral dose of rosuvastatin 2 |
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| Rosuvastatin 3 | Drug | daily oral dose of rosuvastatin 3 |
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| Rosuvastatin 4 | Drug | daily oral dose of rosuvastatin 4 |
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| Placebo to match Rosuvastatin | Drug | daily oral dose of placebo to match rosuvastatin |
|
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks
| 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 | 8 weeks |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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