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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

Tracking Information
First Submitted Date  ICMJE March 27, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date December 1, 2009
Study Start Date  ICMJE April 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8 [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
  • Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8 [ Time Frame: 8 weeks ]
  • Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP [ Time Frame: 8 weeks ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of Patients With Mild To Moderate Hypertension
Official Title  ICMJE 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
Brief Summary The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Experimental: Eplerenone group
    Intervention: Drug: eplerenone
  • Active Comparator: Losartan group
    Intervention: Drug: Losartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 27, 2008)
248
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00649311
Other Study ID Numbers  ICMJE EPLA-0501-072
A6141012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP