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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

This study has been terminated.
(Poor enrollment; termination not due to safety reasons.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00649311
First received: March 27, 2008
Last updated: November 30, 2009
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Hypertension
 Drug: eplerenone
Drug: Losartan
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 248
Study Start Date: April 2003
Study Completion Date: September 2003
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00649311     History of Changes
Other Study ID Numbers: EPLA-0501-072, A6141012
Study First Received: March 27, 2008
Last Updated: November 30, 2009
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Losartan
Eplerenone
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013