Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators want to find out whether a recently introduced combination of two blood pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering effect than a single active substance. In addition the investigators want to find out whether there is a difference in the changes in blood pressure over the course of a day depending on the time when the medications are taken (in the morning or at night). Male and female patients over 18 years of age may participate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin
• Treatments: Amlodipine; Candesartan; Candesartan cilexetil; Olmesartan; Olmesartan Medoxomil

Criteria

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