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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: Lacidipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00328965

LAC103842

VAXAR FEV

Details and patient eligibility

About

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.

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Lacidipine

Other group

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.

Treatment:

Drug: Lacidipine