Dyslipidemia, Hypertension
Conditions
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.
Interventions
DRUGDuowell®
telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%\ 7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%
DRUGTelmisartan
telmisartan 80mg
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in mean central systolic blood pressure | at week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in mean brachial pulse pressure | at week 4 and at week 16 and and at week 28 |
| Changes from baseline in mean brachial systolic blood pressure | at week 4 and at week 16 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 |
Other
| Measure | Time frame |
|---|---|
| Changes from the end of treatment in central systolic blood pressure after 3 months | at 3 months from the end of study |
| Numbers of inconvenience reported by mobile application at each visit | up to 16 weeks |
| Drug compliance between over 50% and less 50% of assessment in mobile application | at week 4 weeks and at week 16 |
| Changes from baseline in central blood pressure according to the frequency of access in mobile application | up to 4 weeks and up to 16 weeks |
Countries
South Korea
Outcome results
None listed