Rancomized controlled trial comparing peripheral edema after treatment with S(-)-amlodipine and amlodpine besylate
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0000450
- Lead Sponsor
- Hanlim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 40
Patients with essential hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg) were eligible. Patients receiving other antihypertensive medications had to discontinue their previous medications and have a blood pressure over 140/90 mmHg and under 180/110 mmHg after the 2 week placebo run-in period.
secondary hypertension; angina pectoris, myocardial infarction, cerebrovascular disease, or clinically significant arrhythmia within the past 6 months; abnormal laboratory test results (serum creatinine levels > 1.5 times the upper limit of normal, serum aspartate aminotransferase of alanine aminotransferase levels >2 times the upper limit of normal); uncontrolled diabetes mellitus (HbA1c = 9%) or use of insulin; and use of antihypertensive drugs other than the study agents. Women of child-bearing age were required to have a negative urine pregnancy test before enrollment, and must use an acceptable method of birth control.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ankle Foot Volume after 12weeks of treatment
- Secondary Outcome Measures
Name Time Method Changes in sitting systolic and diastolic blood pressure after 12 weeks of treatment