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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00649311
• Other study ID #: EPLA-0501-072
• Secondary ID: A6141012
• Status: Terminated
• Phase: Phase 2
• First received: March 27, 2008
• Last updated: November 30, 2009
• Start date: April 2003
• Est. completion date: September 2003

Study information

• Verified date: November 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 248
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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.
• 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

Locations

Country	Name	City	State
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8		8 weeks	No
Secondary	Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8		8 weeks	No
Secondary	Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of =10 mmHg in DBP		8 weeks	No
Secondary	Overall safety and tolerability of all treatments as assessed by change in vital signs, 12-lead electrocardiograms, clinical laboratory tests, and adverse events		8 weeks	Yes

External Links

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