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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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kaohsiung, , Taiwan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- History of mild to moderate hypertension, or newly diagnosed hypertension, defined as
seDBP ≥90 mmHg and

- Withdrawal of all previous antihypertensives prior to the single-blind placebo run-in
period and the double-blind treatment period

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00649311
Pfizer
Terminated
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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A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of Patients With Mild To Moderate Hypertension
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
The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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
  • Experimental: Eplerenone group
    Intervention: Drug: eplerenone
  • Active Comparator: Losartan group
    Intervention: Drug: Losartan
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
248
September 2003
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00649311
EPLA-0501-072
A6141012
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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