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Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years (ELDER)

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: NCT00460915
Recruitment Status : Completed
First Posted : April 17, 2007
Last Update Posted : March 2, 2010
Information provided by:
Korea University Guro Hospital

Brief Summary:

Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years.

Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine on diastolic blood pressure (DBP) in Korean ISH patients aged 60 to 80 years

To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through measurement of markers of inflammation.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Lacidipine & Amlodipine Phase 4

Detailed Description:

Patients will receive lacidipine 4mg and amlodipine 5mg for initial 4 weeks. If SBP is less than 140mmHg at Week 4, subjects continue to take lacidipine 4mg and amlodipine 5mg.

If SBP is ≥140mmHg at Week 4, the dose of lacidipine will be increased to 6mg and amlodipine will be increased to 10mg.

If BP is not controlled under 140mmHg at Week 8, diuretics will be added. For 12 weeks of treatment period, subjects will be visit to clinic at every 4 weeks

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Korea University Guro Hospital
Study Start Date : January 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline in the mean SBP at week 12

Secondary Outcome Measures :
  1. Change from baseline in the mean DBP at week 12
  2. Change from baseline in the CRP at week 12

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female 55 to 80 years of age at screening
  2. The subject has been newly diagnosed as essential hypertension or not treated in the past 2 weeks. If the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments
  3. The subject has a mean seated SBP at screening visit ≥ 140mmHg (as measured by a mercury sphygmomanometer)
  4. Isolated systolic hypertension (ISH) patient (SBP≥ 140mmHg, DBP ≤90mmHg)
  5. If the subject is a female of child-bearing potential, she agrees to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken
  6. The subject has given written informed consent

Exclusion Criteria:

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply :

    1. Mean seated SBP of > 180 mmHg at screening and during the study
    2. Known or suspected secondary hypertension
    3. The subject has anemia defined by hemoglobin concentration < 10.0 g/dL for male or female
    4. The subject has a hemoglobinopathy or peripheral vascular disease
    5. The subject has presence of clinically significant renal or hepatic disease (i.e., subjects with serum creatinine > 1.4 mg/dL;ALT, AST, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal (ULN) reference range
    6. The subject has presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
    7. The subject has a chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e., only use of topical, inhaled or nasal corticosteroids is permissible)
    8. The subject has a clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, or electrocardiogram etc.)
    9. Past medical history or concomitant disease of metabolic acidosis or diabetic ketoacidosis
    10. The subject has a diagnosis of cancer (other than squamous or basal cell) in the past 3 years and is currently receiving treatment for the active cancer
    11. Subject who is taking medication known to affect blood pressure
    12. Known drug or alcohol dependency within 6 months prior to screening as determined by the investigator
    13. Has taken part in a clinical trial using a marketed product, investigational drug or device within 1 month prior to screening.
    14. Hypersensitivity to any component of lacidipine and amlodipine

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): NCT00460915

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Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Korea University Guro Hospital
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Principal Investigator: Hong-seog Seo Korea University Guro Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00460915     History of Changes
Other Study ID Numbers: COL109776
First Posted: April 17, 2007    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: November 2009
Keywords provided by Korea University Guro Hospital:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents