Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication CRESTOR is indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): ∘ in adults with hypercholesterolemia. FDA label
Also known as Crestor
Rosuvastatin Calcium · 7 trials · 8 indications
Proportion of participants that had a correct tass outcome at their initial TASS assessment
Proportion of participants that had a correct tass outcome at their final TASS assessment
Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
| Arm | Type | Description |
|---|---|---|
| Open Label, Single Arm Technology-Assisted Cholesterol Trial | OTHER | Open Label Single Arm study in All-comers population who self-report having concern about high cholesterol or heart health |
| 1 | EXPERIMENTAL | - |
| Rosuvastatin Calcium | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 5 mg rosuvastatin calcium with a Web App (combination product) | COMBINATION_PRODUCT | The combination product will be a Drug (Rosuvastatin calcium 5 mg) and Software as a Medical Device (Web App that features a Technology-Assisted Self-Selection (TASS) tool). Rosuvastatin calcium 5 mg will be taken orally, 1 tablet daily to use for lowering cholesterol, a key risk factor that can lead to heart disease. |
| rosuvastatin calcium | DRUG | 5 mg, oral, once daily, 24 months |
| atorvastatin | DRUG | - |
| CRESTOR | DRUG | - |
Inclusion Criteria: 1. Males, 20-75 years of age 2. Females, 20-75 years of age (This inclusion criterion will be applied until 50 females under the age of 50 years complete the initial TASS assessment in the Web App). After this quota of 50 females under the age of 50 years old is met, the inclusi...
Rosuvastatin calcium is a small molecule HMGCR inhibitor developed by AstraZeneca PLC (ticker AZN). It is being studied in Phase 3 clinical development across cardiovascular and lipid conditions including high cholesterol, hypercholesteremia, familial hypercholesterolaemia, coronary arteriosclerosis, and acute coronary syndromes. It is a statin-class therapy taken to lower cholesterol.
Rosuvastatin calcium is used to lower cholesterol in people with high cholesterol and hypercholesteremia. It is also studied in familial hypercholesterolaemia, coronary arteriosclerosis, and acute coronary syndromes. Development covers both adult and pediatric populations, with trials enrolling participants as young as 6 years old for familial hypercholesterolaemia.
Rosuvastatin calcium targets HMGCR, also known as HMG-CoA reductase, and acts as an inhibitor of this enzyme. By inhibiting HMGCR, the drug reduces cholesterol synthesis in the liver. This mechanism underlies its use across the cholesterol and cardiovascular indications AstraZeneca is studying in Phase 3.
Rosuvastatin calcium is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca has sponsored the clinical trial program for the asset, including studies in high cholesterol, familial hypercholesterolaemia, coronary arteriosclerosis, and CYP2C19 metabolizer populations.
Rosuvastatin calcium is in Phase 3 clinical development. Its trial program includes Phase 3 studies such as TACTiC in high cholesterol and the ASTEROID coronary atheroma study, along with a Phase 1 study in Taiwanese CYP2C19 poor and extensive metabolizers. All listed trials have completed, and no active trials are currently recorded.
Completed trials include NCT04964544 (TACTiC) in high cholesterol with 1,196 participants, NCT01078675 in children and adolescents with familial hypercholesterolaemia, NCT00766025 in Taiwanese CYP2C19 poor and extensive metabolizers, and NCT00240318 (ASTEROID) evaluating coronary atheroma burden in coronary arteriosclerosis.