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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years.
Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine on diastolic blood pressure (DBP) in Korean ISH patients aged 60 to 80 years
To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through measurement of markers of inflammation.
Patients will receive lacidipine 4mg and amlodipine 5mg for initial 4 weeks. If SBP is less than 140mmHg at Week 4, subjects continue to take lacidipine 4mg and amlodipine 5mg.
If SBP is ≥140mmHg at Week 4, the dose of lacidipine will be increased to 6mg and amlodipine will be increased to 10mg.
If BP is not controlled under 140mmHg at Week 8, diuretics will be added. For 12 weeks of treatment period, subjects will be visit to clinic at every 4 weeks
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacidipine & Amlodipine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mean SBP at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mean DBP at week 12 | ||
| Change from baseline in the CRP at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply :
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| Name | Affiliation | Role |
|---|---|---|
| Hong-seog Seo | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Seoul | 152-703 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24384734 | Derived | Na JO, Seo HS, Choi CU, Lim HE, Kim JW, Kim EJ, Han SW, Rha SW, Park CG, Oh DJ; ELDER investigators. Results of a 14-Week, Multicenter, Prospective, Randomized, Open-Label, Noninferiority Clinical Trial Comparing the Antihypertensive Effect and Edema Incidence of Lacidipine and Amlodipine in Older Korean Patients with Mild-to-Moderate Hypertension. Curr Ther Res Clin Exp. 2013 Jun;74:54-61. doi: 10.1016/j.curtheres.2013.02.001. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C060285 | lacidipine |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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