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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Collaborator: Shanghai Sankyo Pharmaceuticals Co., Ltd.
• Treatments: Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

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

• Uncontrolled type 2 diabetes mellitus

• Hypovolemia

• Patients with autoimmune disease