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

Condition(s) targeted: Hypertension

Intervention: eplerenone (Drug); Losartan (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

The purpose this study is to compare the efficacy of epleronone and losartan in patients with mild to moderate hypertension.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8

Secondary outcome:

Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8

Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP

Overall safety and tolerability of all treatments as assessed by change in vital signs, 12-lead electrocardiograms, clinical laboratory tests, and adverse events

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Taipei, Taiwan

Pfizer Investigational Site, Kaohsiung, Taiwan

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: April 2003
Last updated: April 3, 2008