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

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ClinicalTrials.gov Identifier: NCT00649311
Recruitment Status : Terminated (Poor enrollment; termination not due to safety reasons.)
First Posted : April 1, 2008
Last Update Posted : December 1, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: eplerenone Drug: Losartan Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eplerenone group Drug: eplerenone
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 Drug: Losartan
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




Primary Outcome Measures :
  1. Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8 [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8 [ Time Frame: 8 weeks ]
  2. Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP [ Time Frame: 8 weeks ]
  3. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649311


Locations
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00649311     History of Changes
Other Study ID Numbers: EPLA-0501-072
A6141012
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Eplerenone
Spironolactone
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents