Last updated: 11/04/2018 08:34:51

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

GSK study ID
LAC103842
Clinicaltrials.gov ID
NCT00328965
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Change from Baseline in the mean systolic blood pressure (SBP) at Week 12

Timeframe: Baseline (Week 0) and Week 12

Secondary outcomes:

Change from Baseline in the mean diastolic blood pressure (DBP) at Week 12

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline in the flow-mediated vasodilation (FMD) at Week 12

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline in level of high sensitivity C-reactive protein (hsCRP) at Week 12

Timeframe: Baseline (Week 0) and Week 12

Change from Baseline in level of macrophage chemoattractant protein-1 (MCP-1), matrix metalloproteases-9 (MMP-9) and plasminogen activator inhibitor-1 (PAI-1) at Week 12

Timeframe: Baseline (Week 0) and Week 12

Interventions:
  • Drug: Lacidipine
    • Enrollment:
    290
    Primary completion date:
    2005-30-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    lacidipine
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to August 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    35 - 75 years
    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)
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2005-30-08
    Actual study completion date
    2005-30-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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