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The LOW-BP-VIENNA (Lowering Blood Pressure in Primary Care in Vienna) Trial

Phase 1
Conditions
Hypertension
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2014-000668-16-AT
Lead Sponsor
ATVB Verein
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Written informed consent

Previously treated hypertension with office BP = 140/90 mmHg

Age 18 – 80 years

ACE-inhibitor intolerance (experimental arm only)

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 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 420

Exclusion Criteria

Malignant disease with life expectancy < 6 months

Women of childbearing age (no menses for 12 months without an alternative medical cause or permanently sterile due to hysterectomy, bilateral salpingectomy or bilateral oophorectomy)

Contraindications or allergies to olmesartan, amlodipine or hydrochlorothiazide (experimental arm only)

Previously diagnosed chronic kidney disease grade IV or V (estimated glomerular filtration rate (eGFR) < 30 ml/min using the MDRD formula*)

Recent myocardial infarction or stroke within the preceeding 3 months

Participation in another clinical trial

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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