Olmesartan in Essential Hypertension
Phase 3
Completed
- Conditions
- Essential Hypertension
- Interventions
- Registration Number
- NCT00185172
- Lead Sponsor
- Sankyo Pharma Gmbh
- Brief Summary
To test the efficacy and safety of olmesartan in patients with essential hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2333
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 olmesartan medoxomil Olmesartan medoxomil tablets for 8 weeks 1 placebo 2 week placebo run-in 3 olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (8)
PFC Pharma Focus Consultants AG
🇨🇭Zurich, Volketswil, Switzerland
EUROTRIALS Lda
🇵🇹Lisboa, Portugal
IMRO TRAMARKO International bv
🇳🇱Berghem, Netherlands
Biokos Farma s.r.l.
🇮🇹Bologna, Italy
INPUT GmbG
🇩🇪Aachen, Germany
Phidea S.L.
🇪🇸Madrid, Spain
Result Cro
🇦🇹Wien, Austria
Inveresk Ltd.
🇬🇧Edinburgh, United Kingdom