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

Study 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

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

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: olmesartan medoxomil + hydrochlorothiazide
* Drug: olmesartan medoxomil


Participation Criteria
=================
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 Uncontrolled type 2 diabetes mellitus Hypovolemia Patients with autoimmune disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olmesartan medoxomil and hydrochlorothiazide | Drug: olmesartan medoxomil + hydrochlorothiazide<br>* 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<br>|
| Active Comparator: 2<br>olmesartan medoxomil | Drug: olmesartan medoxomil<br>* olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups. |  | Baseline to12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |