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

Daiichi Sankyo

Status and phase

Completed

Phase 3

Conditions

Essential Hypertension

Treatments

Drug: olmesartan medoxomil

Drug: olmesartan medoxomil + hydrochlorothiazide

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00872586

SS-866 CMB/01

Details and patient eligibility

About

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

Enrollment

304 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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