SEVICONTROL-2:Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 89

Inclusion Criteria

male or female patients >= 18 years of age

essential hypertension, i. e. systolic office bp >= 140 mmHg for pre-treated patients or >= 160 mmHg for untreated patients at screening visit and >= 160 mmHg at end of wash-out

signed IC

Exclusion Criteria

•systolic office bp > 180 mm Hg at screening visit
•known hypertensive retinopathy GIII or IV
•recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
•type I diabetes or poorly controlled (HbA1c >= 8) type II diabetes
•chronic heart failure NYHA III or IV
•prior stroke or TIA
•creatinine clearance < 60 ml/min or condition after kidney transplant
•moderately or severely impaired liver function (ALT or AST or bilirubin more than double normal value)
•women of childbearing potential without hghly effective contraception, pregnant or breastfeeding women
•concomitant therapy with lithium
•hemodynamically relevant mitral or aortic valve stenosis (>= II°) or hypertrophic obstructive cardiomyopathy
•concomitant therapy with strong CYP3A4 inhibitors or inductors
•african patients
•concomitant severe psychiatric condition that might impair proper intake of study medication
•life expectancy < 6 months
•night shift workers
•known other mandatory indication for treatment with antihypertensive medications
•parallel participation in other clinical trials

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values after six weeks therapy with a monotherapy with olmesartan 40 mg and further six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan. ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.

Secondary Outcome Measures

Name	Time	Method
Change in systolic/diastolic office blood pressure and mean values (night-time and 24 h for systolic bp and day-time, night-time and 24 h for diastolic bp) after therapy change from candesartan to olmesartan 40 mg and then to a fixed combination of olmesartan 40 mg and amlodipine 10 mg. <br>Comparison of office bp and ABPM (long-term ambulatory blood pressure monitoring) measurements with regard to achieving the target bp values (<140/90 mmHg for OBPM; < 135/85 mmHg for mean day-time ABPM value). OBPM (office bp) and ABPM will be performed at the end of each treatment phase.

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