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

This study is currently recruiting participants.
Verified October 2012 by The Catholic University of Korea
Sponsor:
Collaborators:
Daiichi Sankyo Korea Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Sang Hyun Ihm, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01713920
First received: October 22, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Hypertension
Drug: SEVIKAR
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • change in mean 24-hour ABPM SBP [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 68
Study Start Date: April 2010
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: amlodipine + olemsartan

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713920

Contacts
Contact: Ho-Joong Youn, M.D.,Ph.D. younhj@catholic.ac.kr

Locations
Korea, Republic of
The Catholic University of Korea Bucheon St. Mary's Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Sang-Hyun Ihm, M.D.,Ph.D.         
The Catholic University of Korea Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ho-Joong Youn, M.D.,Ph.D.         
Sponsors and Collaborators
Sang Hyun Ihm
Daiichi Sankyo Korea Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
  More Information

Publications:
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. No abstract available. Erratum in: J Hypertens. 2007 Aug;25(8):1749.

Responsible Party: Sang Hyun Ihm, Associate Professor , Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01713920     History of Changes
Other Study ID Numbers: EARTH
Study First Received: October 22, 2012
Last Updated: October 24, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin Receptor Antagonists
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014