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

Yuhan

Status and phase

Completed

Phase 4

Conditions

Hypertension

Dyslipidemia

Treatments

Drug: Telmisartan

Drug: Duowell®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03267329

YMC023

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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