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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00328965
First received: May 22, 2006
Last updated: August 12, 2010
Last verified: August 2010
  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
Diabetes Mellitus, Type 2
Essential Hypertension
Drug: Lacidipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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. [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]

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. [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]

Study Start Date: November 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Lacidipine
Lacidipine 2, 4, 6mg
Other Name: Lacidipine

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00328965     History of Changes
Other Study ID Numbers: LAC103842, VAXAR FEV
Study First Received: May 22, 2006
Last Updated: August 12, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on November 27, 2014