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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2, Essential Hypertension

Intervention / Treatment
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* Drug: Lacidipine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lacidipine<br>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. | Drug: Lacidipine<br>* Lacidipine 2, 4, 6mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the clinical effectiveness of lacidipine on elevated systolic blood pressure (SBP) in Korean patients aged 35 to 75 years. |  | 12 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korean patients, Type 2 diabetes, Endothelial function, lacidipine, Essential hypertension