fimasartan/ezetimibe/atorvastatin (BR1017) / Boryung Group - LARVOL DELTA

Efficacy and Safety of Fimasartan, Atorvastatin, and Ezetimibe Combination Therapy in Patients With Hypertension and Dyslipidemia: A Randomized, Double-Blind, Multicenter, Therapeutic Confirmatory, Phase III Clinical Trial. (PubMed, Clin Ther) - "Triple combination therapy with FMS + ATO/EZE was superior to dual therapy or monotherapy in reducing both BP and LDL-C levels in patients with essential hypertension accompanied by primary hypercholesterolemia. The safety profile was comparable with that of the individual components, confirming the tolerability and safety of FMS + ATO/EZE therapy. However, the 8-week follow-up period and enrollment of an exclusively Korean cohort may limit the assessment of long-term effects and generalizability to other ethnic populations."

Clinical • Journal • P3 data • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (clinicaltrials.gov) - P3 | N=148 | Completed | Sponsor: Boryung Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Combination therapy • Trial completion • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (clinicaltrials.gov) - P3 | N=156 | Recruiting | Sponsor: Boryung Pharmaceutical Co., Ltd | Trial completion date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Jun 2024 ➔ Sep 2024

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

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B" (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Boryung Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Trial completion • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B" (clinicaltrials.gov) - P1 | N=58 | Recruiting | Sponsor: Boryung Pharmaceutical Co., Ltd

New P1 trial • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Boryung Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders