Diabetes Mellitus, Type 2, Essential Hypertension
Conditions
Keywords
Korean patients, Type 2 diabetes, Endothelial function, lacidipine, Essential hypertension
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.
Interventions
DRUGLacidipine
Lacidipine 2, 4, 6mg
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed