Status:
COMPLETED
Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years
Lead Sponsor:
Korea University Guro Hospital
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hypertension
Eligibility:
All Genders
55-80 years
Phase:
PHASE4
Brief Summary
Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years. Secondary Objectives -To investi...
Detailed Description
Patients will receive lacidipine 4mg and amlodipine 5mg for initial 4 weeks. If SBP is less than 140mmHg at Week 4, subjects continue to take lacidipine 4mg and amlodipine 5mg. If SBP is ≥140mmHg at ...
Eligibility Criteria
Inclusion
- Male or female 55 to 80 years of age at screening
- The subject has been 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
- The subject has a mean seated SBP at screening visit ≥ 140mmHg (as measured by a mercury sphygmomanometer)
- Isolated systolic hypertension (ISH) patient (SBP≥ 140mmHg, DBP ≤90mmHg)
- If the subject is a female of child-bearing potential, she agrees to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken
- The subject has given written informed consent
Exclusion
- A subject will not be eligible for inclusion in this study if any of the following criteria apply :
- Mean seated SBP of \> 180 mmHg at screening and during the study
- Known or suspected secondary hypertension
- The subject has anemia defined by hemoglobin concentration \< 10.0 g/dL for male or female
- The subject has a hemoglobinopathy or peripheral vascular disease
- The subject has presence of clinically significant renal or hepatic disease (i.e., subjects with serum creatinine \> 1.4 mg/dL;ALT, AST, total bilirubin, or alkaline phosphatase \> 2.5 times the upper limit of the normal (ULN) reference range
- The subject has presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
- The subject has a 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)
- The subject has a 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, or electrocardiogram etc.)
- Past medical history or concomitant disease of metabolic acidosis or diabetic ketoacidosis
- The subject has a diagnosis of cancer (other than squamous or basal cell) in the past 3 years and is currently receiving treatment for the active cancer
- Subject who is taking medication known to affect blood pressure
- Known drug or alcohol dependency within 6 months prior to screening as determined by the investigator
- Has taken part in a clinical trial using a marketed product, investigational drug or device within 1 month prior to screening.
- Hypersensitivity to any component of lacidipine and amlodipine
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00460915
Start Date
January 1 2007
End Date
February 1 2010
Last Update
March 2 2010
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, Seoul, South Korea, 152-703