Status:
TERMINATED
A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of Patients With Mild To Moderate Hypertension
Lead Sponsor:
Pfizer
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 effi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00649311
Start Date
April 1 2003
End Date
September 1 2003
Last Update
December 1 2009
Active Locations (2)
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1
Pfizer Investigational Site
Kaohsiung City, Taiwan
2
Pfizer Investigational Site
Taipei, Taiwan