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

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Anderbeck, Germany, 38836
        • Praxis Dr. Reimer
      • Bergisch-Gladbach, Germany, 51429
        • Praxis Dr. Heinz
      • Berlin, Germany, 12043
        • Praxis Dr. Zemmrich
      • Blankenhain, Germany, 99444
        • Praxis Dr. Biedermann
      • Cloppenburg, Germany, 49661
        • St.-Josefs-Hospital
      • Dresden, Germany, 01129
        • Praxis Dr. Pohl
      • Essen, Germany, 45138
        • Praxis Koßler-Wiesweg
      • Frankfurt, Germany, 65929
        • Praxis Dr. Rövenich
      • Kapellendorf, Germany, 99510
        • Praxis Dr. Strzata
      • Ludwigshafen, Germany, 67061
        • Praxis Dr. Pitule
    • Niedersachsen
      • Rastede, Niedersachsen, Germany, 26180
        • Praxis Dr. Loddo
    • Sachsen
      • Leipzig, Sachsen, Germany, 04316
        • Praxis Dr. Paschmionka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olmesartan/Amlodipin fixed combination
candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after six and after 12 weeks
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.
after 6 and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after six and after 12 weeks
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.
after 6 weeks therapy with fixed combination of olmesartan and amlodipine
change in 24 hr mean values and diastolic day mean value
Time Frame: after six and after 12 weeks
after six and after 12 weeks
Distribution of patients over the four dipper types
Time Frame: after six and after 12 weeks
after six and after 12 weeks
Number of patients achieving target values for OBPM and ABPM
Time Frame: after six and after 12 weeks
after six and after 12 weeks
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
From screening visit to end of follow-up, up to 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stephan Lueders, Dr.med., Krankenhaus St.-Josef-Stift, Krankenhausstraße 13, D-49661 Cloppenburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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