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Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea
This study has been completed.
First Received: May 22, 2006   Last Updated: October 13, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00328965
  Purpose

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 Intervention Phase
Essential Hypertension
Drug: Lacidipine
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To investigate the clinical effectiveness of lacidipine on elevated systolic blood pressure (SBP) in Korean patients aged 35 to 75 years.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 257
Study Start Date: April 2005
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328965

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

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: LAC103842
Study First Received: May 22, 2006
Last Updated: October 13, 2008
ClinicalTrials.gov Identifier: NCT00328965     History of Changes
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Study placed in the following topic categories:
Essential Hypertension
Metabolic Diseases
Lacidipine
Diabetes Mellitus
Vascular Diseases
Calcium Channel Blockers
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Calcium, Dietary
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Hypertension

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

ClinicalTrials.gov processed this record on September 11, 2009