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
Phase 3
Completed
- Conditions
- Essential Hypertension
- Interventions
- Registration Number
- NCT00872586
- Lead Sponsor
- Daiichi Sankyo
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 olmesartan medoxomil + hydrochlorothiazide Olmesartan medoxomil and hydrochlorothiazide 2 olmesartan medoxomil olmesartan medoxomil
- Primary Outcome Measures
Name Time Method Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups. Baseline to12 weeks
- Secondary Outcome Measures
Name Time Method 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