A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of Patients With Mild To Moderate Hypertension

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

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.

Inclusion Criteria:

• History of mild to moderate hypertension, or newly diagnosed hypertension, defined as seDBP ≥90 mmHg and <110 mmHg and seSBP <180 mmHg
• Withdrawal of all previous antihypertensives prior to the single-blind placebo run-in period and the double-blind treatment period

Exclusion Criteria:

• Secondary hypertension (e.g., renal, renovascular, or adrenocortical disease, pheochromocytoma, Cushing's syndrome, primary aldosteronism, iatrogenic), severe hypertension, or malignant hypertension
• The patient cannot withdraw from antihypertensives by any route including diuretics, alpha-blockers, betablockers, calcium channel blockers, ACE-I, ARB, or other medications affecting blood pressure; patients who have stable angina and have not had their nitrate dosage changed within the past three months (i.e., on a stable maintenance dose) are eligible for this study; sildenafil citrate, theophylline, or papaverine must not be taken within 24 hours prior to a clinic visit