Sevicontrol-1: Efficacy and safety of a fixed combination of olmesartan 40 mg / amlodipine 10 mg in patients with insufficiently controlled hypertension under monotherapy with candesartan 32 mg - an open phase IIIb trial

Phase 4

• Conditions: I10.90

• Registration Number: DRKS00003272
• Lead Sponsor: IPPMed GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-04
• Study Completion: 2012-09-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

essential hypertension, i. e. systolic OPM >=140 mmHg at screening and >=160 mmHg after two weeks wash-out

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in ABPM mean daytime systolic values and change in systolic OPM. <br><br>ABPM measurements to be performed at the beginning and end of each intervention step.

Secondary Outcome Measures

Name	Time	Method
change in diastolic OPM, change in systolic and diastolic ABPM night mean values, 24 h mean values and diastolic day mean value. Distribution of patients over the four dipper types. Comparison of OPM and ABPM with regard to achievement of target bp values. Efficacy and safety of the fixed combination of olmesartan 40 mg/amlodipine 10 mg. <br><br>ABPM measurements to be performed at the beginning and end of each intervention step.