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CompletedNCT01713920EARTHUpdated Nov 10, 2015

Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to ARB monoTHerapy Using 24h ABPM

A Phase 4 interventional study of SEVIKAR in Hypertension, sponsored by Sang Hyun Ihm, MD PhD. Completed at 2 sites in Korea, Republic of. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2015-11-10.

Sponsored by Sang Hyun Ihm, MD PhD · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
55 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Hypertension

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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 68 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

This is the only study on the registry with Sang Hyun Ihm, MD PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male and female subjects > 55 years
  2. Subject who has consent to participate by signing on the informed consent form

  3. Uncontrolled hypertensive patients defined as:

    • Uncontrolled hypertensive: subjects who are mean SBP ≥ 140 mmHg after being treated with ARB(Valsartan 80mg or Candesartan 8mg) monotherapy during at least 4 weeks.

Exclusion criteria

Exclusion Criteria:

  1. Secondary hypertension
  2. SeSBP ≥ 180mmHg
  3. SeSBP difference ≥ 20mmHg or SeDBP difference ≥ 10mmHg
  4. A history of hypertensive encephalopathy, unstable angina, transient ischemic attack, MI, or any type of revascularization procedure within the last 6 months
  5. Heart failure, second- or third-degree heart block, significant arrhythmia or valvular heart disease
  6. Significant cardiovascular, cerebrovascular, renal, gastrointestinal, or hematologic disease, at the discretion of investigator
  7. Creatinine clearance\<20mL/min and Renal artery stenosis, Renal Transplantation, Patients with only one kidney
  8. Evidence of liver disease as indicated by alanine transaminase (ALT) and aspartate transaminase (AST) and/or total bilirubin ≥ 3 × the upper limit of normal (ULN)
  9. Hyperkalemia (>5.5mmol/L)
  10. Patients with sodium depletion is not correct or Patients with fluid depletion is not correct
  11. Chronic inflammation
  12. Patients with severe eye-related disorders (Retinal bleeding within 6 months, Blindness, Hypertension complications with Retinal micro-aneurysms)
  13. Diabetes mellitus
  14. Hematologic/oncologic, neurologic and psychiatric diseases
  15. Females who were pregnant, breastfeeding, planning a pregnancy or who were of childbearing potential
  16. Contraindications for amlodipine, losartan, olmesartan medoxomil, or other ARBs
  17. With known allergic reaction, lack of response or contraindication to Angiotensin II receptor antagonists
  18. Mean DBP > 110 mmHg
  19. Patients who took antihyperlipidemic agents within 30 days
  20. Subject who have participated in other clinical trial within the last one month
  21. Any subjects who are unable to cooperate with protocol requirements and follow-up procedures or who are in medical condition that is not eligible to be entered in investigators' discretion
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    SEVIKAR

    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.

    Drug: SEVIKAR

Interventions

  • DrugSEVIKAR

    Also known as: amlodipine + olemsartan

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What researchers measure

Primary outcomes

  1. change in mean 24-hour ABPM SBP

    Time frame: from baseline to Week 12

Secondary outcomes

  1. value of cuff SeSBP/SeDBP

    Time frame: baseline, week 4, week 8 and week 12

  2. change in aortic PWV

    Time frame: from baseline to week 4, week 8, week 12

  3. change in 24-hour ABPM DBP

    Time frame: baseline to week 12

  4. change in hsCRP, HOMA-IR, MAU, Uric acid

    Time frame: from baseline to week 12

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Study locations

2 sites
  • 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
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References and documents

Publications

  • Korean National Health & Nutrition Examination Surveys. Available from: URL://http://knhanes.cdc.go.kr/
  • Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, Menard J, Rahn KH, Wedel H, Westerling S. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998 Jun 13;351(9118):1755-62. doi: 10.1016/s0140-6736(98)04311-6. PubMed 9635947 ↗
  • ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002 Dec 18;288(23):2998-3007. doi: 10.1001/jama.288.23.2998. PubMed 12479764 ↗
  • Dahlof B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J; ASCOT Investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005 Sep 10-16;366(9489):895-906. doi: 10.1016/S0140-6736(05)67185-1. PubMed 16154016 ↗
  • Poulter NR, Wedel H, Dahlof B, Sever PS, Beevers DG, Caulfield M, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J, Pocock S; ASCOT Investigators. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA). Lancet. 2005 Sep 10-16;366(9489):907-13. doi: 10.1016/S0140-6736(05)67186-3. PubMed 16154017 ↗
  • Chrysant SG, Melino M, Karki S, Lee J, Heyrman R. The combination of olmesartan medoxomil and amlodipine besylate in controlling high blood pressure: COACH, a randomized, double-blind, placebo-controlled, 8-week factorial efficacy and safety study. Clin Ther. 2008 Apr;30(4):587-604. doi: 10.1016/j.clinthera.2008.04.002. PubMed 18498909 ↗
  • Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197. PubMed 12748199 ↗
  • Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available. Erratum In: J Hypertens. 2007 Aug;25(8):1749. PubMed 17563527 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01713920
Lead sponsor
Sang Hyun Ihm, MD PhD
Collaborators
Daiichi Sankyo Korea Co., Ltd., Daewoong Pharmaceutical Co. LTD.
Responsible party
Sang Hyun Ihm, MD PhD (Associate Professor , Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea) — Sponsor-investigator
First posted
Oct 25, 2012
Start date
Apr 2010
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Nov 10, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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