Trial | NCT01613209  Report issue

Title

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

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    83
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.
Investigation of changes in blood pressure after six weeks therapy with a fixed combination of 40 mg olmesartan and 10 mg amlodipine compared to a monotherapy with 32 mg candesartan. Investigation of changes in dipping-profile after a further six weeks of therapy with the fixed combination when time of intake is switched from morning to evening.
Study Started
Dec 31
2011
Primary Completion
Sep 30
2012
Study Completion
Oct 31
2012
Last Update
May 03
2016
Estimate

Drug Olmesartan/Amlodipin

olmesartan/amlodipine 40/5 mg tablets for 14 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 28 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 42 days (evening)

  • Other names: Sevikar(r)

Drug Candesartan cilexetil

candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,

Olmesartan/Amlodipin fixed combination Experimental

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
No Results Posted