Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine (Sevicontrol1)

Institut für Pharmakologie und Präventive Medizin

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Candesartan cilexetil; Drug: Olmesartan/Amlodipin

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01613209

Sevicontrol-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

Olmesartan/Amlodipin fixed combination

Experimental group

Treatment:

Drug: Candesartan cilexetil

Drug: Olmesartan/Amlodipin