Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

NCT ID: NCT00856271

Last Updated: 2010-09-29

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-04-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

olmesartan medoxomil

Group Type EXPERIMENTAL

olmesartan medoxomil

Intervention Type DRUG

oral tablets, once daily for 8 weeks

2

losartan potassium

Group Type ACTIVE_COMPARATOR

losartan potassium

Intervention Type DRUG

capsules, once daily for 8 weeks

Interventions

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olmesartan medoxomil

oral tablets, once daily for 8 weeks

Intervention Type DRUG

losartan potassium

capsules, once daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and \<110 mmHg, mean seated systolic blood pressure \< 180 mmHg)
* able to give written informed consent

Exclusion Criteria

* known or suspected secondary hypertension
* history of chronic hepatic diseases
* obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
* cardiac arrhythmia
* unstable angina pectoris
* congestive heart insufficiency (New York Heart Association classification III-IV)
* bilateral renal artery stenosis
* isolated renal artery stenosis
* post renal transplantation
* history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment
* retina bleeding/effusion
* insulin dependent diabetes mellitus
* uncontrolled non-insulin dependent diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Sankyo Pharmaceuticals Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Shanghai Sankyo Pharmaceuticals, Co., Ltd.

Principal Investigators

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Vice President

Role: STUDY_DIRECTOR

Sankyo Shanghai Pharmaceuticals

Locations

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Beijing, , China

Site Status

Chongqing, , China

Site Status

Guangzhou, , China

Site Status

Nanjing, , China

Site Status

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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SS-866/01

Identifier Type: -

Identifier Source: org_study_id