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Completed

NCT Number: NCT01613209

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Praxis Dr. Loddo, Rastede, Lower Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candesartan cilexetil

Drug

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

Olmesartan/Amlodipin

Drug

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)

Primary outcomes

  1. Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).

    Time frame: after six and after 12 weeks

    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan

  2. change in systolic OBPM

    Time frame: after 6 and after 12 weeks

    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM.

Secondary outcomes

  1. change in diastolic OBPM

    Time frame: after six and after 12 weeks

    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan

  2. Change in systolic and diastolic ABPM night mean values

    Time frame: after 6 weeks therapy with fixed combination of olmesartan and amlodipine

    first ABPM to be performed after 2 weeks wash-out followed by six weeks monotherapy with candesartan. Second ABPM to be performed after six weeks therapy with the fixed combination, given in the morning.

  3. change in 24 hr mean values and diastolic day mean value

    Time frame: after six and after 12 weeks

  4. Distribution of patients over the four dipper types

    Time frame: after six and after 12 weeks

  5. Number of patients achieving target values for OBPM and ABPM

    Time frame: after six and after 12 weeks

  6. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: From screening visit to end of follow-up, up to 20 weeks

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Registry information

Official study title

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

Acronym: Sevicontrol1

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 7, 2012
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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