SEVICONTROL-1:Efficacy and safety of a fixed combination of olmesartan 40 mg/amlodipin 10 mg in patients with moderate essential hypertension not sufficiently controlled under monotherapy with candesartan 32 mg - an open phase IIIb trial

Conditions: moderate essential arterial hypertension
MedDRA version: 14.0Level: LLTClassification code 10015491Term: Essential hypertension, unspecifiedSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-004235-31-DE

Lead Sponsor: IPPMed GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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
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

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 highly 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

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 pressure reduction and safety of a direct switch from candesarten to a fixed combination of olmesartan and amlodipin.;Secondary Objective: Comparison of evening to morning application of olmesartan 40 mg/amlodipin 10 mg with regard to improving the circadian blood pressure profile and the safety of the fixed combination. ;Primary end point(s): Reduction in systolic day-time mean APBM values after 6 weeks treatment with the fixed combination of 40 mg olmesartan and 10 mg amlodipin as compared to previous monotherapy with candesartant;Timepoint(s) of evaluation of this end point: 6 weeks after switch from candesartan monotherapy to treatment with fixed combination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): reduction of the ratio of non-dippers/inverted dippers ;Timepoint(s) of evaluation of this end point: 6 weeks after switching from morning to evening intake of the fixed combination of olmesartan 40 mg and amlodipine 10 mg