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

Condition(s) targeted: Essential Hypertension

Intervention: olmesartan medoxomil + hydrochlorothiazide (Drug); olmesartan medoxomil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

Official(s) and/or principal investigator(s):
Naotaka Ikegami, VP, Study Director, Affiliation: Shanghai Sankyo Pharmaceuticals Co., Ltd.

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups

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

The response rate in the two treatment groups from baseline to Week 9

The response rate in the two treatment groups from baseline to Week 12

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Beijing, China

Chengdu, China

Chongqing, China

Guang Zhou, China

Hang Zhou, China

Nanjing, China

Shanghai, China

Wuhan, China

Starting date: August 2006
Last updated: September 28, 2010