Metabolic Syndrome
Conditions
Brief summary
This is a Randomized, open-label, 2 groups, parallel design.
Detailed description
This study objective is to compare the safety and efficacy between fixed dose combination (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in hypertensive and hypercholesterolemic patients with metabolic syndrome.
Interventions
DRUGTelmisartan 40mg + Rosuvastatin 20mg
DRUGTelmisartan 80mg + Rosuvastatin 20mg
DRUGTelmisartan 40mg, 80 mg
DRUGRosuvastatin 20mg
Sponsors
Linical Korea
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 19 and 79 years old at screening visit * Subjects who have being used anti-hypertension drugs and Lipid lowering agents over 4weeks before randomization. * Subjects who have been diagnosed with metabolic syndrome according to following criteria Definition of patients with metabolic syndrome: Patients satisfy two of the following criteria at least * Abdominal obesity: Waist measurement \> 90 cm(male), \> 80 cm(female) * Triglyceride(TG) ≥ 150 mg/dL( * High-Density Lipoprotein Cholesterol(HDL-C) \< 40 mg/dL(male), \< 50 mg/dL (female) * Fasting Plasma Glucose(FPG) ≥ 100 mg/dL or Subject who has being used oral hypoglycemic agents * Childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state) * Subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough.
Exclusion criteria
* Subjects who taking anti-hypertension drugs more than three agent * Subjects who have mean Sitting Systolic Blood Pressure(siSBP) \> 160 mmHg (excluded if appliable, one of the arms) * Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension drugs (except if any of the arms) * Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP) III criteria * Subjects who have triglyceride (TG) ≥ 400mg/dL * Subjects who have a difference more than 20mmHg at the mean Sitting Diastolic Blood Pressure(siSBP) measured three times in both arms. * Other exclusions applied
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration. | week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks | From baseline to 4 and 8 weeks |
| Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks | From baseline to 4 and 8 weeks |
| The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks | 4 and 8 weeks |
| The proportion of subjects that the Low Density Lipoprotein-Cholesterol(LDL-C) level reaches treatment goals in accordance with guideline of National Cholesterol Education Program-Adult Treatment Panel(NCEP ATP) III to 4 and 8 weeks | 4 and 8 weeks |
| Change of below indicators from baseline to 4 and 8 weeks | baseline to 4 and 8 weeks |
Countries
South Korea
Outcome results
None listed