Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension

Inclusion criteria

(All of the followings)

• 40 to 75 years old diagnosed with hypertension
• at screening, SBP ≥ 140 mmHg
• at randomization, 130 mmHg ≤ SBP ≤160 mmHg or 80 mmHg ≤ DBP ≤ 100 mmHg
• at screening, ASCVD risk ≥ 5 %
• Those who did not take the dyslipidemic medications during screening or who stopped medication for more than 2 months
• at screening, 130 mg/dL ≤ Calculated (or Measured) Serum LDL-C ≤ 190 mg/dL
• Pregnancy test negative and and who has agreed to perform effective contraception during the clinical trial

Exclusion criteria

(Any of the followings)

• known hypersensitivity to AT-1 receptor blockers or statins
• Those who are treated with secondary hypertension during screening
• Those who are being treated for malignant hypertension during screening
• Those who are taking concurrent medication that may affect blood pressure during screening
• Those who have been diagnosed with myocardial infarction or unstable angina or stroke within the last 6 months at screening
• Patients with heart failure NYHA III-IV or Left Ventricular Ejection Fraction <40% within the last 6 months at screening
• Patients with valve disease with hemodynamically significant (over moderate degree) obstructive
• Those with known atrial fibrillation or atrioventricular conduction disturbance
• Those who show the following numerical values during the screening test

• CPK ≥ 3 times the normal upper limit
• Serum Creatinine > 3 mg/dL
• Serum Potassium > 5.5 mmol/L
• ALT or AST ≥ 3 times the upper normal limit
• Those with known bilateral renal artery stenosis
• Patients who underwent open heart surgery within 4 weeks prior to randomization and who had a cardiac surgery plan
• Those taking statins within 8 weeks before randomization
• Those with severe obstructive, limited or other pulmonary disease history
• Those with non-cardiac disease that can significantly shorten the expected life span to less than 2 years (eg, severe cancer)
• at screening, Anti-HIV Ab, HBsAg, HCV Ab positive