Essential Hypertension
Conditions
Brief summary
To test the efficacy and safety of olmesartan in patients with essential hypertension.
Interventions
OTHERplacebo
Placebo oral tablets for 2 weeks
DRUGolmesartan medoxomil
olmesartan medoxomil oral tablets for 8 weeks
DRUGolmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
Sponsors
Sankyo Pharma Gmbh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 (19 if required by local authorities) to 75 years * Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized * Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg * Written Informed Consent * Mentally competent * Negative pregnancy test in women at a childbearing age at the beginning of the study
Exclusion criteria
* Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension * Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months * Patients with a history or current evidence of congestive heart failure * Bilateral renal artery stenosis * Severe renal insufficiency (serum creatinine greater than 200 micro mol/l) * Severe hepatic impairment or biliary obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan. | From week 8 to week 12 |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12. | 12 weeks |
| To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan. | 12 weeks |
Countries
Austria, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom
Outcome results
None listed