EUCTR2014-003470-17-RO
Active, not recruiting
Phase 1
The efficacy and safety of olmesartan medoxomil/amlodipine fixed combination in patients with grade 1 to grade 2 arterial hypertension. An international randomized, double-blind, 10-week multi-factorial clinical study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Krka, d.d. Novo mesto
- Enrollment
- 997
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
Outcomes
Primary Outcomes
Not specified
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