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

• ClinicalTrials.gov Identifier: NCT00649311
• Recruitment Status: Terminated
• First Posted: April 1, 2008
• Last Update Posted: December 1, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: March 27, 2008
• First Posted Date: April 1, 2008
• Last Update Posted Date: December 1, 2009
• Study Start Date: April 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• 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

• Experimental: Eplerenone group
  Intervention: Drug: eplerenone
• Active Comparator: Losartan group
  Intervention: Drug: Losartan

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 27, 2008): 248
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2003
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00649311
• Other Study ID Numbers: EPLA-0501-072; A6141012
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2009