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

• Status: Completed
• Trial end date: 2020-09-02
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate effect and safety on central blood pressure with Duowell compared to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Telmisartan

Criteria

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

1. CPK ≥ 3 times the normal upper limit

2. Serum Creatinine > 3 mg/dL

3. Serum Potassium > 5.5 mmol/L

4. 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