Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to ARB monoTHerapy Using 24h ABPM (EARTH)
A majority of Korean doctors tend to add other antihypertensive rather than to titrate the same drug.
However, we try to induce doctors to titrate the Sevikar than to add other antihypertensive if patients are not controlled with Sevikar 5/20mg(amlodipine 5mg + omlesartan 20mg). As above, for patients who are not controlled with Sevikar 5/20mg, doctors will proceed to other prescription pattern with other choices of titration to Sevikar 5/40, 10/40mg.
It is important to evaluate BP lowering efficacy of Sevikar through the titration step in patients uncontrolled with Sevikar low dose. Thus, this study is designed to demonstrate the efficacy of Sevikar by titration in patients who are not controlled their BP with low dose of Sevikar.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to Angiotensin Receptor Blocker(ARB) monoTHerapy Using 24h ABPM.|
- change in mean 24-hour ABPM SBP [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: Yes ]
- value of cuff SeSBP/SeDBP [ Time Frame: baseline, week 4, week 8 and week 12 ] [ Designated as safety issue: Yes ]
- change in aortic PWV [ Time Frame: from baseline to week 4, week 8, week 12 ] [ Designated as safety issue: No ]
- change in 24-hour ABPM DBP [ Time Frame: baseline to week 12 ] [ Designated as safety issue: Yes ]
- change in hsCRP, HOMA-IR, MAU, Uric acid [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Subjects who are eligible for the inclusion and exclusion criteria will be treated with Sevikar 5/20mg for 4 weeks. If subjects fail to reach the SBP threshold of SeSBP≥ 140mmHg after 4-week treatment, they will receive Sevikar 5/40mg for 4 weeks. At the end of 4-week treatment, subjects who fail to reach SBP threshold will receive Sevikar 10/40mg for 4 weeks. Subjects who can reach SBP threshold will continue to treat with current dose until 12 weeks.
Other Name: amlodipine + olemsartan
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713920
|Korea, Republic of|
|The Catholic University of Korea Bucheon St. Mary's Hospital|
|Bucheon, Korea, Republic of|
|The Catholic University of Korea Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of|