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

Study Overview
=================
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.

Official Title
-----------------
A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Evaluate the Central Aortic Pressure Effect Between Fixed Dose Combination (Duowell® Tab) and Monotherapy of Telmisartan in Mild Dyslipidemia Patients With Hypertension

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Duowell®
* Drug: Telmisartan


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duowell® Tab.<br>Once daily during 16 wks | Drug: Duowell®<br>* telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5% 7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%<br>|
| Active Comparator: Telmisartan<br>Once daily during 16 wks | Drug: Telmisartan<br>* telmisartan 80mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in mean central systolic blood pressure |  | at week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in mean brachial systolic blood pressure |  | at week 4 and at week 16 and at week 28 | 
| Changes from baseline in mean brachial pulse pressure |  | at week 4 and at week 16 and and at week 28 | 
| Changes from mean brachial diastolic blood pressure |  | at week 4 and at week 16 and at week 28 | 
| Changes from baseline in augmentation index |  | at week 16 and at week 28 | 
| Changes from baseline in carotid femoral pulse wave velocity |  | at week 16 and at week 28 |