Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2003-09-30

Brief Summary

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The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.

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Detailed Description

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Conditions

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Essential 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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1

olmesartan medoxomil

Group Type EXPERIMENTAL

olmesartan medoxomil

Intervention Type DRUG

olmesartan medoxomil oral tablets, once daily for up to 12 weeks

2

losartan potassium

Group Type ACTIVE_COMPARATOR

losartan potassium

Intervention Type DRUG

losartan oral tablets, once daily for up to 12 weeks

Interventions

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olmesartan medoxomil

olmesartan medoxomil oral tablets, once daily for up to 12 weeks

Intervention Type DRUG

losartan potassium

losartan oral tablets, once daily for up to 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diastolic BP 95 mm Hg - 114 mm Hg inclusive
* No participation in any clinical trial for the last 3 months

Exclusion Criteria

* Secondary hypertension
* Malignant hypertension
* Severe arterial hypertension
* Significant cardiovascular disease
* History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder
* Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No