A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of Patients With Mild To Moderate Hypertension
The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Clinical Protocol For A Double-Blind, Randomized, Active- Controlled Comparison Study Of The Antihypertensive Effect Of Eplerenone Versus Losartan In Patients With Mild To Moderate Hypertension|
- Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2003|
|Study Completion Date:||September 2003|
|Experimental: Eplerenone group||
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.
|Active Comparator: Losartan group||
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
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.