Essential Hypertension
Conditions
Brief summary
Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.
Interventions
DRUGolmesartan medoxomil
DRUGamlodipine
Sponsors
Sankyo Pharma Gmbh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization.
Exclusion criteria
* Secondary hypertension of any aetiology; * Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s); * History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment. | — |
| Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment. | — |
| Safety and tolerability | — |
Countries
Germany
Outcome results
None listed