A Multicenter, Single-arm, Prospective, Observational Study to Evaluate the Safety and Effectiveness of a Fixed-dose Combination Containing Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patient With Hypertension and Hypercholesterolemia

To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia

Start Date01 Sep 2020

Sponsor / Collaborator

LG Chem Ltd.

NCT02662894 / WithdrawnPhase 3

Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.

Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.

Start Date01 Oct 2019

Sponsor / Collaborator

EMS SA (Brazil)

NCT01918358 / CompletedPhase 1

A Randomized, Open-label, Single Dose Crossover Study to Compare the Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg in Healthy Male Volunteers

To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab 160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg and Crestor® (Rosuvastatin) 20 mg in healthy male volunteers

Start Date01 Dec 2012

Sponsor / Collaborator

LG Life Sciences Ltd.

100 Clinical Results associated with Valsartan/Rosuvastatin Calcium

100 Translational Medicine associated with Valsartan/Rosuvastatin Calcium

100 Patents (Medical) associated with Valsartan/Rosuvastatin Calcium

Literatures (Medical) associated with Valsartan/Rosuvastatin Calcium

Drug Design, Development and Therapy

Effectiveness and Safety of a Fixed-Dose Combination of Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patients with Concomitant Hypertension and Hyperlipidemia: An Observational Study

Article

Author: Shin, Won Yong ; Kim, Jeong Su ; Kim, Won Ho ; Jang, Ji Yong ; Lee, Kwang Je ; Ryu, Jae-Kean ; Beom, Jong Wook ; Yoon, Young Won ; Kang, Seok-Min ; Cho, Yun-Hyeong

PurposeThis study aimed to assess the effectiveness and safety of a fixed-dose combination of rosuvastatin and valsartan (Rovatitan^®) in Korean patients with concomitant hypertension and hyperlipidemia.Patients and MethodsA total of 1008 eligible patients with concomitant hypertension and hyperlipidemia were enrolled and treated for 12 weeks. Both upward and downward drug dose titrations were allowed based on the investigator's discretion. This study evaluated the effectiveness of the study drug, defined by the percentage of patients achieving the blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) treatment targets. Additionally, regression analyses were conducted to evaluate the factors associated with the effectiveness and safety of the study drug. Of the 1008 patients enrolled in the study, 911 were analyzed for clinical effectiveness.ResultsAt 12 weeks, 84.6% and 75.9% of patients treated with the study drug achieved their BP and LDL-C targets, respectively, and 64.8% of patients achieved both targets simultaneously. Furthermore, the percentage of patients who achieved their BP and LDL-C treatment targets demonstrated a trend across the respective risk groups; the higher the risk group, the lower the success of attaining the respective target. This trend was also observed regardless of the prior antihypertensive and/or lipid-lowering treatments. According to regression analysis, poor metabolic profiles, including a higher body mass index (BMI) and higher BP and LDL-C levels at baseline, were significantly associated with treatment failure for BP. Among the 1005 patients included in the safety analysis, 17 patients (1.7%) experienced serious adverse events; however, none were considered related to the study drug.ConclusionThe study drug used for the treatment of concomitant hypertension and hyperlipidemia in a real-world setting was effective and was well tolerated. Therefore, the study drug is suggested as a good alternative to increase patient convenience and compliance, particularly in those taking multiple medications.

100 Deals associated with Valsartan/Rosuvastatin Calcium

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R&D Status

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Indication	Country/Location	Organization	Date
Hyperlipidemias	KR	LG Life Sciences Ltd.	01 Jan 2016
Hypertension	KR	LG Life Sciences Ltd.	01 Jan 2016

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