None listed
Conditions
Interventions
Drug : Experimental arm : Nebivolol 5mg/ Rosuvastatin 20mg
Control arm 1(Rosuvastatin) : Nebivolol 5mg Placebo/ Rosuvastatin 20mg
Control arm 2(Nebivolol) : Nebivolol 5mg/ Rosuvastatin 20mg Placebo
Sponsors
Elyson Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and 79 years 2. Signed informed consent 3. At screening, Systolic Blood Pressure(SBP)140-179/Diastolic Blood Pressure(DBP)90-109(mmHg), LDL-C ? 250, Triglyceride < 400 4. At randomization visit, if the subject is classified by Cardiovascular Risk Factors, the below condition should be complied - Risk factor 0-1: SBP140-179/DBP90-109(mmHg), LDL-C: 160~250, Triglyceride <400 - Risk factor?2, 10 year risk<10%: SBP140-179/DBP90-109(mmHg), LDL-C: 160~250, Triglyceride <400 - Risk factor?2, 10 year risk = 10 – 20 %: SBP140-179/DBP90-109(mmHg),LDL-C: 130~250, Triglyceride <400 - CHD/CHD risk equivalents or 10 year risk>20 %: SBP140-179/DBP90-109(mmHg), LDL-C: 100~250, Triglyceride <400
Exclusion criteria
Exclusion criteria: 1.When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference = 20mmHg or sitDBP difference =10mmHg 2. Patients with orthostatic hypotension accompanied symptom 3. Patients diagnosed with secondary hypertension or suspected of secondary hypertension by the Investigator (coarctation of aorta, primary aldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing syndrome, etc.). 4. Severe heart disease (NYHA class III-IV heart failure), clinically significant valvular disease of the heart, myocardial infarction and unstable angina 5. Patients with past history of autoimmune disease uncontrolled by medicine, such as chronic rheumatoid arthritis, systemic lupus erythematosus, etc. 6. Patients with past history of bronchospasm or asthma 7. Patients with poorly controlled diabetic patients (HemoglobinA1c =9.0%) 8. If patients have clinically significant renal or hepatic diseases , or significant hematologic test findings at screening (serum creatinine = 2mg/dL, AST or ALT [aspartate transaminase or alanine transaminase] =2 times of the ULN). 9. Surgical or internal disease likely to significantly change absorption, distribution, metabolism, and elimination of drug 10. All chronic inflammatory patients requiring chronic inflammatory treatment 11. Creatine phosphokinase (CPK) =3 times of the upper limit of normal (ULN). 12. Patients with history of malignant tumors including leukemia and lymphoma in the past 5 years 13. Patients with past clinical history of alcohol or drug abuse 14. Patients with hypersensitivity to investigational product 15. Patients who have been administered another investigational product within 30 days prior to participation in this clinical study 16. Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study 17. Patients who are deemed ineligible as subject in Investigator's judgment for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LDL Cholesterol;Change in Systolic Blood Pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Diastolic Blood Pressure;Change in Diastolic Blood Pressure, Systolic Blood Pressure;Change in LDL Cholesterol;Rate of patients achieving a therapeutic purpose (therapeutic purpose for blood pressure: < 140/90 mmHg);Change from baseline in total cholesterol, TG, HDL-C ;Percentage of patients reaching treatment goals according to NCEP ATP III Guideline | — |
Countries
Korea, Republic of
Contacts
Public ContactCheol Kim
Seoul National University Bundang Hospital
Outcome results
None listed