In breve
Questo articolo riassume gli studi clinici che stanno valutando Rosuvastatin Calcium. Le ricerche esaminano efficacia, sicurezza e altri risultati in persone con malattie reumatiche infiammatorie, rischio cardiovascolare alto, tromboembolismo venoso e volontari sani.
Punti chiave
- Gli studi su Rosuvastatin Calcium nei dati forniti valutano soprattutto prevenzione cardiovascolare, intolleranza alle statine e tromboembolismo venoso. Sono presenti trial di Fase 3 in popolazioni di pazienti con malattie reumatiche infiammatorie, rischio cardiovascolare alto e tromboembolismo venoso. Ci sono anche studi di Fase 1 in volontari sani per capire come il farmaco si comporta nell’organismo e per confrontare la bioequivalenza. Gli endpoint principali includono eventi cardiovascolari maggiori, uso della statina a 12 mesi, recidiva di eventi venosi e misure farmacocinetiche. Alcuni studi usano placebo o confrontano strategie di trattamento diverse.
Overview of the clinical research
The available trials on Rosuvastatin Calcium study different clinical questions, not just one disease. Some trials test prevention strategies for cardiovascular disease, while others look at people with statin intolerance, venous thromboembolism, or healthy volunteers for drug testing and bioequivalence.
Across the source data, the studies are interventional, meaning the researchers assign a treatment, placebo, or comparison strategy to measure outcomes in a planned way.
Who is being studied
One large Phase 3 trial includes people with chronic inflammatory rheumatic disease, such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, or systemic lupus erythematosus.
Another Phase 3 study focuses on people with statin intolerance and high cardiovascular risk, including those with previous cardiovascular disease or familial hypercholesterolemia, which means a hereditary form of very high cholesterol.
The SAVER trial studies people with venous thromboembolism, including pulmonary embolism and deep vein thrombosis.
Two Phase 1 studies enrolled healthy volunteers: one looked at the effect of nirmatrelvir/ritonavir on Rosuvastatin Calcium exposure, and another compared a test capsule with reference products under fasting conditions.
Trial phases and study designs
The largest studies in the data are Phase 3 trials, which usually test whether a strategy works in a larger patient group and measure clinical outcomes.
The two smaller studies are Phase 1 trials, which are earlier studies. In these trials, researchers measured how the drug behaves in the body or whether two formulations are similar enough to be considered bioequivalent.
One Phase 3 study uses a strategy based on carotid ultrasound to find patients at higher cardiovascular risk and then treat them, while comparing this approach with current guideline-based care.
Another Phase 3 study uses an n=1 design, which means the participant’s own results are used to guide counseling and treatment decisions, with the goal of improving statin use over time.
The SAVER trial compares Rosuvastatin Calcium with placebo to see whether it lowers the rate of recurrent major venous thromboembolism.
The Phase 1 pharmacokinetic study tested a single oral dose of rosuvastatin with multiple doses of nirmatrelvir/ritonavir in healthy participants.
The bioequivalence study compared a test capsule containing Rosuvastatin/Amlodipine/Ramipril with separate reference products in healthy men and women under fasting conditions.
Main endpoints measured
In the rheumatic disease trial, the main endpoint is the occurrence of a major cardiovascular event, such as acute myocardial infarction, stroke, unstable angina requiring hospital admission, revascularization for peripheral artery disease, or death due to cardiovascular disease.
In the statin-intolerance trial, the main endpoint is self-reported statin use 12 months after inclusion, which shows whether people kept taking the treatment.
In the SAVER trial, the main endpoint is symptomatic recurrent major venous thromboembolism, meaning a new serious clot event like proximal deep vein thrombosis or a larger pulmonary embolism during follow-up.
In the Phase 1 drug-interaction study, the main endpoints are AUCinf and Cmax of rosuvastatin, which measure total drug exposure and peak blood level.
In the bioequivalence study, the main endpoints are AUC and Cmax, with 90% confidence intervals used to compare the test product with the reference products.
Main trial summaries
2025-521086-28-00 is a Phase 3 interventional study in 1,250 patients with inflammatory rheumatic diseases. It tests a prevention strategy based on carotid ultrasound and measures major cardiovascular events.
2023-507489-20-00 is a Phase 3 trial in 249 people with statin intolerance and high cardiovascular risk. It uses a randomized, double-blind, cross-over n=1 approach and measures statin use after 12 months.
NCT04319627, the SAVER trial, is a Phase 3 study in 2,500 patients with venous thromboembolism, pulmonary embolism, or deep vein thrombosis. It compares Rosuvastatin Calcium with placebo and measures recurrent major venous events.
2023-503570-20-00 is a completed Phase 1 study in 12 healthy volunteers. It examined the effect of nirmatrelvir/ritonavir on Rosuvastatin Calcium pharmacokinetics.
2023-503822-38-00 is a completed Phase 1 bioequivalence study in 60 healthy subjects. It compared a fixed-dose capsule with reference products under fasting conditions.
Important terms explained
Primary outcome means the main result the researchers want to measure in a trial.
Enrollment is the number of people planned or included in the study.
Placebo is a comparison treatment with no active medicine, used to see whether the study drug makes a difference.
Bioequivalence means the test product is compared with reference products to see if the body absorbs them in a similar way.
Pharmacokinetics describes how the body handles a drug, including the amount in the blood and how long it stays there.
Carotid ultrasound is an imaging test of the neck arteries, used in one trial to help find patients at higher cardiovascular risk.
Familial hypercholesterolemia is a hereditary condition that causes very high cholesterol and higher cardiovascular risk.
Deep vein thrombosis is a clot in a deep vein, usually in the leg.
Pulmonary embolism is a clot that travels to the lungs and can be serious.