Status:
COMPLETED
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
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00872586
Start Date
August 1 2006
End Date
August 1 2007
Last Update
September 29 2010
Active Locations (8)
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1
Beijing, China
2
Chengdu, China
3
Chongqing, China
4
Guangzhou, China