Essential Hypertension
Conditions
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
Interventions
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
DRUGolmesartan medoxomil
olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks
Sponsors
Shanghai Sankyo Pharmaceuticals Co., Ltd.
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups. | Baseline to12 weeks |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed