The efficacy and safety of olmesartan medoxomil/amlodipine fixed combination in patients with mild to moderately elevated blood pressure. An international randomized, double-blind, 10-week clinical Investigatio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 997

Inclusion Criteria

•Mean SeDBP of 90 to 109 mm Hg at the screening ( Visit 1/screening) and the baseline (Visit 2)
•Men and women, aged 18-75 years
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 560
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

•History of hypersensitivity to any components of the medicines used in the trial or history of intolerance to amlodipine and/or olmesartan medoxomil
•Known secondary arterial hypertension (e.g. pheochromocytoma, primary aldosteronism, renal artery stenosis)
•History of left ventricular hypertrophy or obstruction of the left ventricular outflow tract (e.g. hemodynamically significant aortic stenosis)
•Ischaemic heart disease or ischaemic cerebrovascular disease
•Heart failure on medication therapy
•Chronic disease other than arterial hypertension requiring chronic use of beta-blockers or calcium antagonists (e.g. tachyarrhythmia, glaucoma)
•Clinically and laboratory evident biliary obstruction with both jaundice and increased total serum bilirubin over 50 micromol / l
•Renal impairment (creatinine clearance < 60 mL/min)
•Previous or current therapy with olmesartan medoxomil and amlodipine taken concomitantly
•Current therapy with:
•Other antihypertensive drugs, if introduced/modified less than 6 weeks prior to enrolment
•Any not allowed” medication(s) listed in section 6.2.
•Any acute disease (severe infection, exacerbation or uncontrolled phase of a chronic disease, major trauma, surgery) within 30 days prior to screening visit
•Following clinically relevant laboratory or ECG findings:
• i.e. significant anaemia with hemoglobin less than 80 g/l,
•significant thrombocytopenia with platelet count less than 50.000/microliter
•serum AST and/or ALT and/or ALP of more than 3 x ULN (upper limit of normal)
•hyperkalaemia (serum potassium of more than 5 mmol/l)
•A-V block grade 2 or 3
•ECG signs of acute ischemia
•Symptomatic bradycardia with heart rate less than 50/min
•Smoking more than 20 cigarettes/day
•Pathological clinical states that could affect subject’s compliance, or have any impact on subject’s short-term survival rate (malignant diseases, excessive alcohol consumption, drug abuse or drug addiction, psychiatric conditions)
•Pregnancy and lactation
•Women with no reliable contraception
•Subjects currently participating in another clinical trial
•Subject’s refusal to participate with the investigator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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