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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

NCT ID: NCT00649311

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2003-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Eplerenone group

Group Type EXPERIMENTAL

eplerenone

Intervention Type DRUG

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 group

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kaohsiung City, , Taiwan

Site Status

Pfizer Investigational Site

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=EPLA-0501-072&StudyName=A%20Study%20To%20Evaluate%20The%20Efficacy%20Of%20Eplerenone%20Compared%20With%20Losartan%20For%20The%20Treatment%20Of%20Patients%20With%20Mild%20To%20Moderate%20Hyperte

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Other Identifiers

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A6141012

Identifier Type: -

Identifier Source: secondary_id

EPLA-0501-072

Identifier Type: -

Identifier Source: org_study_id