{"id":"abt-335-and-rosuvastatin-calcium","safety":{"commonSideEffects":[{"rate":null,"effect":"Myalgia or muscle pain"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Rhabdomyolysis (rare with combination)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This combination targets dyslipidemia through dual mechanisms: ABT-335 activates PPARα to increase lipoprotein lipase activity and reduce VLDL production, thereby lowering triglycerides and increasing HDL. Rosuvastatin competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, effectively reducing LDL cholesterol. Together, they address multiple lipid abnormalities in patients at cardiovascular risk.","oneSentence":"ABT-335 (fenofibrate) reduces triglycerides and raises HDL cholesterol by activating peroxisome proliferator-activated receptor alpha (PPARα), while rosuvastatin calcium lowers LDL cholesterol by inhibiting HMG-CoA reductase.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:58:45.890Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dyslipidemia with elevated triglycerides and low HDL cholesterol"},{"name":"Cardiovascular risk reduction in patients with mixed dyslipidemia"}]},"trialDetails":[{"nctId":"NCT00680017","phase":"PHASE3","title":"30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2008-06","conditions":"Dyslipidemia, Kidney 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ABT-335 and Rosuvastatin When Administered Concomitantly","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2008-01","conditions":"Dyslipidemia, Renal Insufficiency","enrollment":37},{"nctId":"NCT00487136","phase":"PHASE1","title":"Interaction Between ABT-335, Rosuvastatin and Warfarin","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2007-06","conditions":"Healthy","enrollment":45},{"nctId":"NCT00491530","phase":"PHASE3","title":"A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia","status":"COMPLETED","sponsor":"Abbott","startDate":"2007-06","conditions":"Mixed Dyslipidemia","enrollment":310},{"nctId":"NCT00300430","phase":"PHASE3","title":"Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.","status":"COMPLETED","sponsor":"Abbott","startDate":"2006-09","conditions":"Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia","enrollment":1911},{"nctId":"NCT00300482","phase":"PHASE3","title":"Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood","status":"COMPLETED","sponsor":"Abbott","startDate":"2006-03","conditions":"Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia","enrollment":1445}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ABT-335 / Rosuvastatin Combination (ABT-143)","ABT-335","TRILIPIX"],"phase":"phase_3","status":"active","brandName":"ABT-335 and rosuvastatin calcium","genericName":"ABT-335 and rosuvastatin calcium","companyName":"AstraZeneca","companyId":"astrazeneca","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ABT-335 (fenofibrate) reduces triglycerides and raises HDL cholesterol by activating peroxisome proliferator-activated receptor alpha (PPARα), while rosuvastatin calcium lowers LDL cholesterol by inhibiting HMG-CoA reductase. Used for Dyslipidemia with elevated triglycerides and low HDL cholesterol, Cardiovascular risk reduction in patients with mixed dyslipidemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}