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

August 12, 2010 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, M.D., PH.D., GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

May 22, 2006

First Submitted That Met QC Criteria

May 22, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Estimate)

August 16, 2010

Last Update Submitted That Met QC Criteria

August 12, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAC103842
  • VAXAR FEV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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