Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea
Diabetes Mellitus, Type 2, Essential Hypertension
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
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
Other
Lacidipine
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.