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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duowell® Tab. | Experimental | Once daily during 16 wks |
|
| Telmisartan | Active Comparator | Once daily during 16 wks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duowell® | Drug | telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in mean central systolic blood pressure | at week 16 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Drug compliance between over 50% and less 50% of assessment in mobile application | at week 4 weeks and at week 16 |
Inclusion Criteria (All of the followings)
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Telmisartan | Drug | telmisartan 80mg |
|
| 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 |
| Drug compliance between over 50% and less 50% of assessment in mobile application | up to 3 months end of study |
| 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 |
| D009750 | Nutritional and Metabolic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |