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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Open Label, Multi-centre, Single Arm Phase IV Study to Evaluate the Antihypertensive Effect of Lacidipine in Mild to Moderate Essential Hypertension Patients With Type 2 Diabetes in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328965
• Other study ID #: LAC103842
• Secondary ID: VAXAR FEV
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2006
• Last updated: August 12, 2010
• Start date: November 2004
• Est. completion date: May 2006

Study information

• Verified date: August 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Essential Hypertension
• Hypertension

Intervention

Drug:
• Lacidipine
Lacidipine 2, 4, 6mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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