NCT00328965

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
Last Updated

August 16, 2010

Status Verified

August 1, 2010

Enrollment Period

1.5 years

First QC Date

May 22, 2006

Last Update Submit

August 12, 2010

Conditions

Diabetes Mellitus, Type 2Essential Hypertension

Keywords

Korean patientsType 2 diabetesEndothelial functionlacidipineEssential hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (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.

    12 weeks from baseline

Study Arms (1)

Lacidipine

OTHER

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

Interventions

LacidipineDRUG

Lacidipine 2, 4, 6mg

Lacidipine

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Acute or chronic metabolic acidosis or a history of diabetic ketoacidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Essential Hypertension

Interventions

lacidipine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • GSK Clinical Trials, M.D., PH.D.

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 22, 2006

First Posted

May 24, 2006

Study Start

November 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

August 16, 2010

Record last verified: 2010-08