Status:
COMPLETED
Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension
Lead Sponsor:
Yuhan Corporation
Conditions:
Hypertension
Dyslipidemia
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03267329
Start Date
September 11 2017
End Date
September 2 2020
Last Update
April 6 2021
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea