Clinical trial NCT00328965: Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Essential Hypertension
Keywords: Korean patients
Type 2 diabetes
Endothelial function
lacidipine
Essential hypertension
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To investigate the clinical effectiveness of lacidipine on elevated systolic blood pressure (SBP) in Korean patients aged 35 to 75 years.
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks from baseline
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, M.D., PH.D.
role: STUDY_DIRECTOR
References: