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Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea

Primary Purpose

Diabetes Mellitus, Type 2, Essential Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lacidipine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Korean patients, Type 2 diabetes, Endothelial function, lacidipine, Essential hypertension

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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) Mean seated SBP at screen visit = 130mmHg (as measured by a mercury sphygmomanometer) Type 2 diabetes (American Diabetes Association criteria 2004) and HbA1C <11% Agree to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken if the subject a female of child-bearing potential Provide written informed consent Exclusion criteria: Mean seated SBP of > 180 mmHg Known or suspected secondary hypertension Anemia defined by haemoglobin concentration < 10.0 g/dL Hemoglobinopathy or peripheral vascular disease Clinically significant renal or hepatic disease (i.e., subjects with serum creatinine = 2.0 mg/dL; Alanine aminotransferase, Aspartate aminotransferase, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal reference range) Unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment 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) Female who is lactating, pregnant, or planning to become pregnant 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, laboratory tests, or electrocardiogram etc.) Acute or chronic metabolic acidosis or a history of diabetic ketoacidosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Lacidipine

    Arm Description

    All subjects who meet eligiblity criteria receive 2mg for the first 4 weeks in an open manner. If target systolic blood pressure is not ahcieved, subject can increase the dose to 4mg and then 6mg consequently.

    Outcomes

    Primary Outcome Measures

    To investigate the clinical effectiveness of lacidipine on elevated systolic blood pressure (SBP) in Korean patients aged 35 to 75 years.

    Secondary Outcome Measures

    To investigate the clinical effectiveness of lacidipine on elevated diastolic blood pressure and endothelial function by flow-medicated vasodilation and measurement of markers of inflammation in Korean patients aged 35 to 75 years with type 2 diabetes.

    Full Information

    First Posted
    May 22, 2006
    Last Updated
    August 12, 2010
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00328965
    Brief Title
    Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea
    Official Title
    An Open Label, Multi-centre, Single Arm Phase IV Study to Evaluate the Antihypertensive Effect of Lacidipine in Mild to Moderate Essential Hypertension Patients With Type 2 Diabetes in Korea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was designed to evaluate the anti-hypertensive efficacy of lacidipine in hypertensives with Type 2 diabetes and effectiveness on endothelial cell function in Korean population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Essential Hypertension
    Keywords
    Korean patients, Type 2 diabetes, Endothelial function, lacidipine, Essential hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    Lacidipine
    Arm Type
    Other
    Arm Description
    All subjects who meet eligiblity criteria receive 2mg for the first 4 weeks in an open manner. If target systolic blood pressure is not ahcieved, subject can increase the dose to 4mg and then 6mg consequently.
    Intervention Type
    Drug
    Intervention Name(s)
    Lacidipine
    Intervention Description
    Lacidipine 2, 4, 6mg
    Primary Outcome Measure Information:
    Title
    To investigate the clinical effectiveness of lacidipine on elevated systolic blood pressure (SBP) in Korean patients aged 35 to 75 years.
    Time Frame
    12 weeks from baseline
    Secondary Outcome Measure Information:
    Title
    To investigate the clinical effectiveness of lacidipine on elevated diastolic blood pressure and endothelial function by flow-medicated vasodilation and measurement of markers of inflammation in Korean patients aged 35 to 75 years with type 2 diabetes.
    Time Frame
    12 weeks from baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: 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) Mean seated SBP at screen visit = 130mmHg (as measured by a mercury sphygmomanometer) Type 2 diabetes (American Diabetes Association criteria 2004) and HbA1C <11% Agree to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken if the subject a female of child-bearing potential Provide written informed consent Exclusion criteria: Mean seated SBP of > 180 mmHg Known or suspected secondary hypertension Anemia defined by haemoglobin concentration < 10.0 g/dL Hemoglobinopathy or peripheral vascular disease Clinically significant renal or hepatic disease (i.e., subjects with serum creatinine = 2.0 mg/dL; Alanine aminotransferase, Aspartate aminotransferase, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal reference range) Unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment 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) Female who is lactating, pregnant, or planning to become pregnant 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, laboratory tests, or electrocardiogram etc.) Acute or chronic metabolic acidosis or a history of diabetic ketoacidosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials, M.D., PH.D.
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea

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