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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00328965
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : August 16, 2010
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Essential Hypertension Drug: Lacidipine Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2004
Primary Completion Date : May 2006
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Lacidipine
Lacidipine 2, 4, 6mg

Primary Outcome Measures :
  1. To investigate the clinical effectiveness of lacidipine on elevated systolic blood pressure (SBP) in Korean patients aged 35 to 75 years. [ Time Frame: 12 weeks from baseline ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks from baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328965

Sponsors and Collaborators
Study Director: GSK Clinical Trials, M.D., PH.D. GlaxoSmithKline

ClinicalTrials.gov Identifier: NCT00328965     History of Changes
Other Study ID Numbers: LAC103842
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010

Keywords provided by GlaxoSmithKline:
Korean patients
Type 2 diabetes
Endothelial function
Essential hypertension

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action