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

INTERVENTION: 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 Concentration number: 20‐ INN or Proposed INN: AMLODIPINE CAS Number: 88150‐42‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ 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 Concentration number: 40‐ INN or Proposed INN: AMLODIPINE CAS Number: 88150‐42‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ 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 Concentration number: 40‐ INN or Proposed INN: AMLODIPINE CAS Number: 88150‐42‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Product Name: Olmesartan/Amlodipine/Hydrochlorothiazide Pharmaceutical Form: Tablet INN or Proposed INN: OLMESARTAN MEDOXOMIL CAS Number: 144689‐63‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ INN or Proposed INN: AMLODIPINE CAS Number: 88150‐42‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ INN or Proposed INN: HYDROCHLOROTHIAZIDE Other descriptive name: HYDROCHLOROTHIAZIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5‐ Product Name: Olmesartan/Amlodipine/Hydrochlorothiazide Pharmaceutical Form: Tablet INN or Proposed INN: OLMESARTAN MEDOXOMIL CAS Number: 144689‐63‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ INN or Proposed INN: AMLODIPINE CAS Number: 88150‐42‐9 Concentration unit: mg milligram(s) Concentration type: equal Con CONDITION: Hypertension Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] SECONDARY OUTCOME: 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 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 PRIMARY OUTCOME: 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. 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. 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. Timepoint(s) of evaluation of this end point: The primary outcome measure will be analysed after 6 months of follow‐up