Status:
COMPLETED
Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Essential Hypertension
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00328965
Start Date
November 1 2004
End Date
May 1 2006
Last Update
August 16 2010
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