Status:
COMPLETED
Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The goal of this study is to compare the antihypertensive effect and tolerability of S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate hypertension.
Eligibility Criteria
Inclusion
- patients are required to have a mean cuff sitting diastolic blood pressure of ≥90 and ≤109 mmHg after successful completion of the 2-week placebo run-in period
Exclusion
- any serious disorder that could limit the ability of the patient to participate in the study
- significant cardiovascular disease (angina, myocardial infarction, cerebrovascular disease, or significant arrhythmia in the preceding 6 months)
- uncontrolled diabetes mellitus (serum glucose level ≥140 mg/dl)
- insulin dependent diabetes mellitus (type I)
- secondary hypertension
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00289406
Start Date
January 1 2006
End Date
February 1 2006
Last Update
March 6 2007
Active Locations (1)
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1
SKChemicals
Seoul, South Korea