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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01713920
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : November 10, 2015
Daiichi Sankyo Korea Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Sang Hyun Ihm, MD PhD, The Catholic University of Korea

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: SEVIKAR Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : April 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Other Name: amlodipine + olemsartan

Primary Outcome Measures :
  1. change in mean 24-hour ABPM SBP [ Time Frame: from baseline to Week 12 ]

Secondary Outcome Measures :
  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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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01713920

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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
Sponsors and Collaborators
Sang Hyun Ihm, MD PhD
Daiichi Sankyo Korea Co., Ltd.
Daewoong Pharmaceutical Co. LTD.

Korean National Health & Nutrition Examination Surveys. Available from: URL://
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. Erratum in: J Hypertens. 2007 Aug;25(8):1749.

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Responsible Party: Sang Hyun Ihm, MD PhD, Associate Professor , Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea Identifier: NCT01713920     History of Changes
Other Study ID Numbers: EARTH
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action