A Randomized, Double-blind, Double-dummy, Multicenter Clinical Trial to Evaluate the Additional Efficacy and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension, Who Fail to Attain the Blood Pressure Goals With Olmesartan Medoxomil 20mg Monotherapy

Daiichi Sankyo0 sites304 target enrollmentAugust 2006

ConditionsEssential Hypertension

Interventionsolmesartan medoxomil + hydrochlorothiazide olmesartan medoxomil

Drugsolmesartan medoxomil + hydrochlorothiazide olmesartan medoxomil

Overview

Phase: Phase 3
Intervention: olmesartan medoxomil + hydrochlorothiazide
Conditions: Essential Hypertension
Sponsor: Daiichi Sankyo
Enrollment: 304
Primary Endpoint: Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

August 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daiichi Sankyo

Eligibility Criteria

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

Arms & Interventions

1

Olmesartan medoxomil and hydrochlorothiazide

Intervention: olmesartan medoxomil + hydrochlorothiazide

2

olmesartan medoxomil

Intervention: olmesartan medoxomil

Outcomes

Primary Outcomes

Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.

Time Frame: Baseline to12 weeks

Secondary Outcomes

The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups(8 weeks (week 5 to week 12))
The mean change of trough seated diastolic blood pressure and seated systolic blood pressure from Week 5 to Week 9 between the two treatment groups(5 weeks (Week 5 to week 9))
The response rate in the two treatment groups from baseline to Week 9(Baseline to 9 weeks)
The response rate in the two treatment groups from baseline to Week 12(Baseline to 12 weeks)