None listed
Conditions
Interventions
Drug : 1.Test group : Amlodipine/Valsartan 10/160mg, Rosuvatatin 20mg, Valsartan 160mg(Placebo) ? One 8-week oral administration once a day(Visit your institution every 4 weeks)
2.Reference group1 : A
Sponsors
Kyung Dong Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Aged between 19 and 79 years 2.Patient with dyslipidemia and hypertension 3.Those who satisfy the following test results -msSBP<180 mmHg -DBP<110mmHg -LDL-C= 250mg/dL - Triglyceride<400mg/dL 4.Those who have the ability and willingness to voluntarily agree to take part in the clinical trial and participate in the test
Exclusion criteria
Exclusion criteria: 1.At screening, siSBP difference is = 20 mmHg or siDBP difference is =10 mmHg 2.Patients with orthostatic hypotension with symptoms 3.Patients with secondary hypertension and patients with secondary dyslipidemia 4.Those who have confirmed the following medical history or surgery 1)Acute coronary syndrome within 6 months of screening, transient ischemic attack, cerebrovascular disease, coronary revascularization, arrhythmia requiring treatment 2)Severity or malignant retinopathy within 6 months of screening 3)Genetic angioedema or renin angiotensin Aldosterone system when administered to a drug or similar drugs, angioedema 4)Myopathies including rhabdomyolysis 5)Autoimmune disease 6)Alcohol or substance abuse within one year from screening 7)Major mental illness 8)Malignant tumors within 5 years from screening 5.Those with accompanying accompanying diseases and hematologic laboratory abnormalities 1)Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, immunologically significant aortic or mitral stenosis 2)Uncontrolled thyroid dysfunction (TSH) = 1.5 x Upper organ normal upper limit 3)Unregulated diabetes 4)Severe heart failure of New York heart assocation Class III/IV 5)Severe renal failure (CLcr < 30mL/min) 6)AST or ALT = 2 X ULN 7)CK = 2 X ULN 8)Hyperkalemia 9)Hyponatremia 6.Patients with a history of gastrointestinal surgery (except simple cecal surgery or hernia surgery) with a gastrointestinal disease that may affect the absorption of clinical trial medications 7.Those who are expected to receive / take the following drugs / foods during the clinical trial period including screening 1)Drugs for Clinical Trials Other antihypertensive agents and antihyperlipidemic agents 2)Other drugs or foods that can affect blood pressure / blood lipids 3)Drugs known to have drug interactions with other clinical trial drugs 8.Those who have clinical signs of hypersensitivity to drugs or components 9.Pregnant or lactating women and those who do not consent to appropriate contraceptive practice Women and men 10.Those who have received other clinical trial drugs within 30 days before screening, or those who have received clinical medical devices 11.Those who can not participate in clinical trials according to the testee's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Test group versus Reference2 group : Change in Mean Sitting Systolic Blood Pressure [Time Frame : 8 weeks];Test group versus Reference1 group : Percent Change in Low Density Lipoprotein-Cholesterol [Time Frame : 8 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| Test group versus Reference2 group : Change in Mean Sitting Systolic Blood Pressure [Time Frame : 4weeks, 8 weeks];Percent Change in Low Density Lipoprotein-Cholesterol [Time Frame : 4weeks, 8 weeks];Test group versus Reference1 group : Percent Change in Low Density Lipoprotein-Cholesterol [Time Frame : 4 weeks];Test group versus Reference1 group, Change in Systolic Blood Pressure [Time Frame : 4weeks, 8 weeks];Change in Mean Sitting Diastolic Blood Pressure [Time Frame : 4weeks, 8 weeks];Normal Blood Pressure Percentage [Time Frame : 8 weeks];Blood Pressure response Percentage [Time Frame : 8 weeks];Value Reach Percent of Object Low Density Lipoprotein-Cholesterol [Time Frame : 8 weeks] | — |
Countries
Korea, Republic of
Contacts
Public ContactChongjin Kim
Kyung Hee University Hosipital at Gangdong
Outcome results
None listed