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

March 1, 2010 updated by: Korea University Guro Hospital

Korea University Guro Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

204

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in the mean SBP at week 12

Secondary Outcome Measures

Outcome Measure
Change from baseline in the mean DBP at week 12
Change from baseline in the CRP at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Hong-seog Seo, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 16, 2007

First Posted (Estimate)

April 17, 2007

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

March 1, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL109776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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