Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension

NCT ID: NCT00890591

Last Updated: 2009-06-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-08-31

Brief Summary

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In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

Intervention Type DRUG

olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks

Interventions

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olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage 1 and 2 hypertension without treatment for at least 2 weeks
* Women with no risk of becoming pregnant

Exclusion Criteria

* Study participation could result in risk to health of subject
* Cardiovascular disease
* Secondary hypertension or stage 3 hypertension
* Myocardial infarction within the last 6 months
* Congestive heart failure
* Pulmonary edema
* Valvular alterations or rheumatic cardiopathy
* Clinically relevant conduction disorders significant arrhythmias
* Alcohol or illicit drug use
* Medication abuse
* Pregnant or nursing women
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Daiichi Sankyo Brazil

Other Identifiers

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SPB-OM-0106

Identifier Type: -

Identifier Source: org_study_id

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