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Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension

NCT ID: NCT00872586

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

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-08-31

Brief Summary

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This study is designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy

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 and hydrochlorothiazide

Group Type EXPERIMENTAL

olmesartan medoxomil + hydrochlorothiazide

Intervention Type DRUG

olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 20mg oral tablets + hydrochlorothiazide 12.5 mg oral tablets, once daily for up to 8 weeks

2

olmesartan medoxomil

Group Type ACTIVE_COMPARATOR

olmesartan medoxomil

Intervention Type DRUG

olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks

Interventions

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olmesartan medoxomil + hydrochlorothiazide

olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 20mg oral tablets + hydrochlorothiazide 12.5 mg oral tablets, once daily for up to 8 weeks

Intervention Type DRUG

olmesartan medoxomil

olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At Visit 3, mean seated diastolic blood pressure (SeDBP) ≥ 95 mmHg and \< 110 mmHg, AND mean seated systolic blood pressure (SeSBP) ≥140 mmHg and \< 180 mmHg
* At Visit 4, mean SeDBP ≥ 90 mmH
* No significant disorder in blood, kidney, liver, cardiovascular system or endocrinology system

Exclusion Criteria

* Patients with known or suspect secondary hypertension
* Unstable angina
* History of acute myocardial infarct, or PTCA or surgical cardiac procedures 3 months before entry into this study
* Prior or current congestive heart failure (NYHA grade III or IV), hypertrophic obstructive cardiomyopathy, valvular disease or rheumatic heart disease
* Arrhythmia of clinical significance
* Bilateral renal artery stenosis, isolated renal artery stenosis, post kidney transplantation
* Acute glomerular nephritis
* Gout sufferers, even with the normal serum uric acid at entry
* Retinal hemorrhage /exudate
* Type 1 diabetes mellitus
* Uncontrolled type 2 diabetes mellitus
* Hypovolemia
* Patients with autoimmune disease
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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Naotaka Ikegami, VP

Role: STUDY_DIRECTOR

Shanghai Sankyo Pharmaceuticals Co., Ltd.

Locations

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Beijing, , China

Site Status

Chengdu, , China

Site Status

Chongqing, , China

Site Status

Guangzhou, , China

Site Status

Hangzhou, , China

Site Status

Nanjing, , China

Site Status

Shanghai, , China

Site Status

Wuhan, , China

Site Status

Countries

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China

Other Identifiers

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SS-866 CMB/01

Identifier Type: -

Identifier Source: org_study_id