The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.
This Phase 2 study EPLA-0501-072 (A6141012) was conducted beginning 02 April 2003 and was prematurely terminated due to poor enrollment on 12 September 2003. There were no statistical analyses of efficacy conducted because the numbers of patients enrolled were insufficient for inferential analysis due to the poor enrollment. There were no serious adverse events or deaths reported during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
248
Eplerenone 50 mg oral film-coated tablet once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to eplerenone 100 mg oral film-coated tablet once daily for 4 weeks.
Losartan 50 mg oral capsule once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to losartan 100 mg oral capsule once daily for 4 weeks
Pfizer Investigational Site
Kaohsiung City, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8
Time frame: 8 weeks
Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8
Time frame: 8 weeks
Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP
Time frame: 8 weeks
Overall safety and tolerability of all treatments as assessed by change in vital signs, 12-lead electrocardiograms, clinical laboratory tests, and adverse events
Time frame: 8 weeks
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