amlodipine/rosuvastatin (DP-R212) / Alvogen - LARVOL DELTA

CORONA: Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia (clinicaltrials.gov) - P4; N=324; Recruiting; Sponsor: Yuhan Corporation; Trial completion date: Feb 2021 ➔ Dec 2021; Trial primary completion date: Aug 2020 ➔ Jul 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Dyslipidemia • Hypertension • Metabolic Disorders

A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia (clinicaltrials.gov) - P3; N=145; Completed; Sponsor: Hanmi Pharmaceutical Company Limited; Recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Hypertension • Metabolic Disorders

Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia. (PubMed, J Clin Hypertens (Greenwich)) - P3 | "Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688."

Clinical • Journal • Cardiovascular • CNS Disorders • Dyslipidemia • Hypertension • Metabolic Disorders

Pharmacokinetic Drug Interactions Between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers. (PubMed, Adv Ther) - "When amlodipine, valsartan, and rosuvastatin were coadministered to healthy volunteers, the pharmacokinetic exposure to valsartan was decreased, but no change in exposure to amlodipine and rosuvastatin occurred. All treatments were well tolerated."

Clinical • Journal • PK/PD data • Dyslipidemia

Pharmacokinetic interactions between telmisartan/amlodipine and rosuvastatin after multiple oral administrations in healthy Korean male subjects. (PubMed, Drug Des Devel Ther) - "The objective of this study was to evaluate the pharmacokinetic interaction between telmisartan/amlodipine fixed dose combination and rosuvastatin in healthy Korean male volunteers. The increase in systemic exposure to rosuvastatin caused by telmisartan/amlodipine co-administration would not be clinically significant in practice. Nevertheless, an appropriately designed two-sequence crossover study is needed to confirm the results of this study."

Clinical • Journal • PK/PD data

Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study. (PubMed, Clin Ther) - P3 | "Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316."

Clinical • Journal • P3 data

Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial. (PubMed, Clin Ther) - P3; "Fixed-dose combinations of telmisartan, amlodipine, and rosuvastatin decreased BP and LDL-C in patients with hypertension and dyslipidemia. The safety and tolerability profiles of fixed-dose telmisartan, amlodipine, and rosuvastatin combination therapy were comparable with those of telmisartan plus amlodipine or telmisartan plus rosuvastatin. ClinicalTrials.gov identifier: NCT03088254."

Clinical • Journal

A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension. (PubMed, J Clin Hypertens (Greenwich)) - "No serious adverse events or adverse drug reactions were observed in all groups. In hypertensive patients with dyslipidemia, combination treatment with rosuvastatin 20 mg + amlodipine 10 mg effectively reduced blood pressure and LDL-C levels while maintaining safety."

Clinical • Journal

Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of separate tablets in healthy Korean subjects. (PubMed, Int J Clin Pharmacol Ther) - "Both drugs were safe and well tolerated, and the pharmacokinetic profiles were comparable between the treatments."

Clinical • Journal • PK/PD data

Thrombocytopenia Triggering Troponinemia: A Therapeutic Travesty (AHA 2019) - "She was on amlodipine and rosuvastatin for hypertension and hyperlipidemia and was a nonsmoker...She was treated for cefuroxime-induced thrombocytopenia with methylprednisone...80 mg atorvastatin was administered...Cardiac complications in TTP have been poorly outlined despite existing data attributing cardiac involvement to be a major cause of mortality. Severe thrombocytopenia may limit coronary intervention but should not preclude the use of mortality lowering drugs namely beta blockers, ACE inhibitors and statins."

A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia (clinicaltrials.gov) - P3; N=129; Recruiting; Sponsor: Hanmi Pharmaceutical Company Limited

Clinical • New P3 trial

ANICHKOV study: the effect of combined hypotensive and lipid-lowering therapy on cardiovascular complications in patients of high and very high risk. (PubMed, Ter Arkh) - "The results of the study demonstrated a sufficient hypolipidemic effect and high safety of Mertenil® and Ekvamer®. A higher adherence to the combined preparation than to two monodrugs was noted. Achieving target levels of BP and LDL-C is problematic, which dictates the expediency of using fixed combinations of drugs, especially in primary prevention."

Clinical • Journal

Lisinopril, Amlodipine, Rosuvastatin as a Novel Fixed Combination in the Fight Against Cardiovascular Disease (PubMed, Kardiologiia) - "The efficacy of each of the components and their combined administration in primary and secondary prevention of cardiovascular disease has been demonstrated in clinical studies. The convenience of several drugs combination in a single tablet increases adherence to therapy facilitating regular intake of all treatment components and reliably reducing the risk of cardiovascular complications."

Journal

CORONA: Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia (clinicaltrials.gov) - P4; N=324; Recruiting; Sponsor: Yuhan Corporation

Clinical • Combination therapy • New P4 trial