Clinical trial NCT00872586: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Sankyo Pharmaceuticals Co., Ltd.
First posted: 2009-03-31
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.
timeFrame: Baseline to12 weeks
Secondary outcomes:
measure: The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups
timeFrame: 8 weeks (week 5 to week 12)
measure: 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
timeFrame: 5 weeks (Week 5 to week 9)
measure: The response rate in the two treatment groups from baseline to Week 9
timeFrame: Baseline to 9 weeks
measure: The response rate in the two treatment groups from baseline to Week 12
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Guang Zhou
country: China
city: Hang Zhou
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Wuhan
country: China
Study officials:
affiliation: Shanghai Sankyo Pharmaceuticals Co., Ltd.
name: Naotaka Ikegami, VP
role: STUDY_DIRECTOR
References: