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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000668-16-AT

Enrollment

Unknown

Registered

2014-03-12

Start date

2014-05-06

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Product Name: Olmesartan/Amlodipine Pharmaceutical Form: Tablet INN or Proposed INN: OLMESARTAN MEDOXOMIL CAS Number: 144689-63-4 Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this project is to enhance blood pressure control in primary care by introducing a standardized and simplified titration regime with single pill combinations to practitioners (family doctors or specialists for internal medicine) in the participating districts. Furthermore, intensified antihypertensive treatment will enhance awareness of practitioners for adequate blood pressure control. ;Secondary Objective: To this date there is no data on blood pressure control available in the setting of primary care in Vienna. Finally, this study will help to identify subjects with treatment resistant hypertension. ;Primary end point(s): The primary analysis will compare the proportion of patients achieving the pre-defined blood pressure target between patients randomised to practices with either standard care or guided care. A logistic regression model will be applied to compare the primary endpoint at patient level. ;Timepoint(s) of evaluation of this end point: The primary outcome measure will be analysed after 6 months of follow-up	—

Measure

Time frame

Main Objective: The aim of this project is to enhance blood pressure control in primary care by introducing a standardized and simplified titration regime with single pill combinations to practitioners (family doctors or specialists for internal medicine) in the participating districts. Furthermore, intensified antihypertensive treatment will enhance awareness of practitioners for adequate blood pressure control. ;Secondary Objective: To this date there is no data on blood pressure control available in the setting of primary care in Vienna. Finally, this study will help to identify subjects with treatment resistant hypertension. ;Primary end point(s): The primary analysis will compare the proportion of patients achieving the pre-defined blood pressure target between patients randomised to practices with either standard care or guided care. A logistic regression model will be applied to compare the primary endpoint at patient level. ;Timepoint(s) of evaluation of this end point: The primary outcome measure will be analysed after 6 months of follow-up

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Secondary

Measure	Time frame
Secondary end point(s): ABPM: Mean systolic and diastolic BP over 24 hours, daytime and nighttime will be compared between patients randomised to practices with either standard care or guided care, using a 2-sample t test or Mann Whitney U test where appropriate. The proportion of patients achieving target blood pressure at practice-level will be analysed using a 2-sample t test or Mann Whitney U test where appropriate. Systolic and diastolic office BP will be compared between patients randomised to practices with either standard care or guided care, using a 2-sample t test or Mann Whitney U test where appropriate. ;Timepoint(s) of evaluation of this end point: The primary outcome measure will be analysed after 6 months of follow-up	—

Measure

Time frame

Secondary end point(s): ABPM: Mean systolic and diastolic BP over 24 hours, daytime and nighttime will be compared between patients randomised to practices with either standard care or guided care, using a 2-sample t test or Mann Whitney U test where appropriate. The proportion of patients achieving target blood pressure at practice-level will be analysed using a 2-sample t test or Mann Whitney U test where appropriate. Systolic and diastolic office BP will be compared between patients randomised to practices with either standard care or guided care, using a 2-sample t test or Mann Whitney U test where appropriate. ;Timepoint(s) of evaluation of this end point: The primary outcome measure will be analysed after 6 months of follow-up

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Countries

Austria

Contacts

Public ContactClinical Trial Outpatient Clinic

Wilhelminenhospital, 3rd Medical Department for Cardiology

thomas.weiss@meduniwien.ac.at00431491502374

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026