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
- Conditions
- moderate hypertensionMedDRA version: 14.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-004249-42-DE
- Lead Sponsor
- IPPMed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy in blood significantly improved blood pressure reduction after six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg as compared to monotherapy with 32 mg candesartan and safety of sequential therapy change via 6 weeks monotherapy with olmesartan;Secondary Objective: Comparison of OBDM and ABPM values with regard to achieving target bp values. <br><br>Distribution of patients over different ABPM dipping regimes.;Primary end point(s): Reduction in systolic daytime mean ABDM values after six weeks therapy with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan;Timepoint(s) of evaluation of this end point: After 6 weeks monotherapy with olmesartan followed by six weeks under therapy with the fixed combination.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Reduction of 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 a fixed combination of olmesartan 40 mg and amlodipine 10 mg. <br>Comparison of office bp and ABPM measurements with regard to achieving the target bp values (<140/90 mmHg for OBPM; < 135/85 mmHg for mean day-time ABPM value).;Timepoint(s) of evaluation of this end point: After 6 weeks monotherapy with olmesartan followed by six weeks under therapy with the fixed combination.