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NCT Number: NCT01713920

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

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Secondary hypertension
  • SeSBP ≥ 180mmHg
  • SeSBP difference ≥ 20mmHg or SeDBP difference ≥ 10mmHg
  • A history of hypertensive encephalopathy, unstable angina, transient ischemic attack, MI, or any type of revascularization procedure within the last 6 months
  • Heart failure, second- or third-degree heart block, significant arrhythmia or valvular heart disease
  • Significant cardiovascular, cerebrovascular, renal, gastrointestinal, or hematologic disease, at the discretion of investigator
  • Creatinine clearance<20mL/min and Renal artery stenosis, Renal Transplantation, Patients with only one kidney
  • 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)
  • Hyperkalemia (>5.5mmol/L)
  • Patients with sodium depletion is not correct or Patients with fluid depletion is not correct
  • Chronic inflammation
  • Patients with severe eye-related disorders (Retinal bleeding within 6 months, Blindness, Hypertension complications with Retinal micro-aneurysms)
  • Diabetes mellitus
  • Hematologic/oncologic, neurologic and psychiatric diseases
  • Females who were pregnant, breastfeeding, planning a pregnancy or who were of childbearing potential
  • Contraindications for amlodipine, losartan, olmesartan medoxomil, or other ARBs
  • With known allergic reaction, lack of response or contraindication to Angiotensin II receptor antagonists
  • Mean DBP > 110 mmHg
  • Patients who took antihyperlipidemic agents within 30 days
  • Subject who have participated in other clinical trial within the last one month
  • 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

Treatment and study plan

SEVIKAR

Drug

Other names: amlodipine + olemsartan

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

Sponsors and collaborators

Lead sponsor

Sang Hyun Ihm, MD PhD

Other

Collaborators

  • Daewoong Pharmaceutical Co. LTD.
  • Daiichi Sankyo Korea Co., Ltd.

Registry information

Official study title

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

Acronym: EARTH

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2012
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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