In short
Clinical trials investigating Rosuvastatin Calcium are studying how it may help in different patient groups, including people with inflammatory rheumatic diseases, statin intolerance, venous thromboembolism, and healthy volunteers. These studies look at safety, effectiveness, bioequivalence, and treatment strategies in Phase 1 and Phase 3 research.
Key points
- Clinical trials of Rosuvastatin Calcium are studying several different patient groups and research questions. The Phase 3 trials focus on preventing major cardiovascular events in people with inflammatory rheumatic diseases, helping people with statin intolerance, and reducing recurrent venous thromboembolism. The Phase 1 trials focus on healthy volunteers and study how the medicine behaves in the body or how it compares with other products. Across the trials, the main outcomes include major cardiovascular events, recurrent blood clots, statin use after 12 months, and drug exposure measures. These studies are designed to test both treatment strategies and how Rosuvastatin Calcium performs in different settings.
Clinical trials overview
The available studies on Rosuvastatin Calcium are testing different research questions in different groups of people. Some trials look at prevention of heart and blood vessel problems, while others study how the medicine behaves in the body or compare one product with another.
Phase 3 studies in patient groups
Three of the trials are Phase 3 studies, which means they are testing the treatment in larger groups and looking closely at how well it works and how safe it is.
One Phase 3 trial is studying people with chronic inflammatory rheumatic diseases, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and systemic lupus erythematosus. This study is testing a strategy for primary prevention, which means trying to stop the first major cardiovascular event before it happens. The trial compares a strategy based on carotid ultrasound with the current strategy based on clinical guidelines.
Another Phase 3 trial is in people with statin intolerance and high cardiovascular risk, including patients with previous cardiovascular disease or familial hypercholesterolemia. This study uses an n=1 study design, which is a randomized, double-blind, cross-over trial with counseling on each patient’s own treatment results. The goal is to see whether this approach increases statin use and lowers the use of PCSK9i compared with usual care after 12 months.
The third Phase 3 study is the SAVER Trial in patients with venous thromboembolism, including pulmonary embolism and deep vein thrombosis. It compares generic Rosuvastatin Calcium with placebo to see whether the treatment lowers the rate of symptomatic recurrent major venous thromboembolism during follow-up.
Phase 1 studies in healthy volunteers
Two trials are Phase 1 studies, which are usually smaller and often focus on how a medicine is handled by the body or whether two products are similar.
One completed Phase 1 trial studied healthy volunteers who received nirmatrelvir/ritonavir with Rosuvastatin Calcium in the setting of COVID-19 research. The study looked at pharmacokinetics, meaning how the body absorbs and processes the medicine, and measured AUCinf and Cmax of rosuvastatin.
The other completed Phase 1 trial was a bioequivalence study in healthy men and women under fasting conditions. It compared a test capsule containing Rosuvastatin, amlodipine, and ramipril with separate reference products taken together. The goal was to see whether the test product and the reference products gave similar exposure in the body.
What the trials measure
The main outcome in the inflammatory rheumatic disease trial is the occurrence of a major cardiovascular event, including acute myocardial infarction, stroke, hospital admission for unstable angina, arterial revascularization for peripheral artery disease, or death due to cardiovascular disease.
The statin-intolerance trial measures self-reported statin use 12 months after inclusion. This helps show whether the counseling-based n=1 approach can improve long-term use of statins.
The SAVER Trial measures symptomatic recurrent major venous thromboembolism, defined as proximal deep vein thrombosis or segmental or larger pulmonary embolism, from randomization until the end of follow-up.
The Phase 1 drug-interaction study measures AUCinf and Cmax of rosuvastatin after multiple doses of nirmatrelvir/ritonavir. The bioequivalence study measures AUC and Cmax and compares test-to-reference ratios, with acceptance limits of 80.00% to 125.00%.
Who may take part
Each trial has a different target population, so participation depends on the study question.
- People with inflammatory rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, or systemic lupus erythematosus may be considered for the prevention study.
- People with statin intolerance and high cardiovascular risk, including prior cardiovascular disease or familial hypercholesterolemia, are the target group for the n=1 study.
- People with venous thromboembolism, pulmonary embolism, or deep vein thrombosis are the focus of the SAVER Trial.
- Healthy volunteers took part in the Phase 1 studies, including both the drug-interaction study and the bioequivalence study.
Key points for patients
These trials show that Rosuvastatin Calcium is being studied in several different ways, not just for one disease.
Some studies are trying to prevent serious heart and blood vessel events, while others are testing whether the medicine can help after blood clots or improve long-term statin use in people who had trouble taking statins before.
The Phase 1 studies are smaller and are mainly about body exposure and product comparison, which helps researchers understand how the medicine performs in controlled settings.