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

NCT ID: NCT00328965

Last Updated: 2010-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-05-31

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.

Conditions

Diabetes Mellitus, Type 2; Essential Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Lacidipine

Intervention Type: DRUG

Lacidipine 2, 4, 6mg

Interventions

Lacidipine

Lacidipine 2, 4, 6mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Principal Investigators

GSK Clinical Trials, M.D., PH.D.

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

VAXAR FEV

Identifier Type: -

Identifier Source: secondary_id

LAC103842

Identifier Type: -

Identifier Source: org_study_id