- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613209
Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine (Sevicontrol1)
May 2, 2016 updated by: Institut für Pharmakologie und Präventive Medizin
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
Intervention / Treatment
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
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Anderbeck, Germany, 38836
- Praxis Dr. Reimer
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Bergisch-Gladbach, Germany, 51429
- Praxis Dr. Heinz
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Berlin, Germany, 12043
- Praxis Dr. Zemmrich
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Blankenhain, Germany, 99444
- Praxis Dr. Biedermann
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Cloppenburg, Germany, 49661
- St.-Josefs-Hospital
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Dresden, Germany, 01129
- Praxis Dr. Pohl
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Essen, Germany, 45138
- Praxis Koßler-Wiesweg
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Frankfurt, Germany, 65929
- Praxis Dr. Rövenich
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Kapellendorf, Germany, 99510
- Praxis Dr. Strzata
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Ludwigshafen, Germany, 67061
- Praxis Dr. Pitule
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Niedersachsen
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Rastede, Niedersachsen, Germany, 26180
- Praxis Dr. Loddo
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Sachsen
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Leipzig, Sachsen, Germany, 04316
- Praxis Dr. Paschmionka
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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:
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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
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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
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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
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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.
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after 6 weeks therapy with fixed combination of olmesartan and amlodipine
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change in 24 hr mean values and diastolic day mean value
Time Frame: after six and after 12 weeks
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after six and after 12 weeks
|
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Distribution of patients over the four dipper types
Time Frame: after six and after 12 weeks
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after six and after 12 weeks
|
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Number of patients achieving target values for OBPM and ABPM
Time Frame: after six and after 12 weeks
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after six and after 12 weeks
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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
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From screening visit to end of follow-up, up to 20 weeks
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sevicontrol-1
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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