Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine
Information source: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Candesartan cilexetil (Drug); Olmesartan/Amlodipin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Institut für Pharmakologie und Präventive Medizin Official(s) and/or principal investigator(s): Stephan Lueders, Dr.med., Principal Investigator, Affiliation: Krankenhaus St.-Josef-Stift, KrankenhausstraĆe 13, D-49661 Cloppenburg
Summary
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.
Clinical Details
Official 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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).change in systolic OBPM
Secondary outcome: change in diastolic OBPMChange in systolic and diastolic ABPM night mean values change in 24 hr mean values and diastolic day mean value Distribution of patients over the four dipper types Number of patients achieving target values for OBPM and ABPM Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 (>= IIĀ°) 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
Locations and Contacts
Praxis Dr. Reimer, Anderbeck 38836, Germany
Praxis Dr. Heinz, Bergisch-Gladbach 51429, Germany
Praxis Dr. Zemmrich, Berlin 12043, Germany
Praxis Dr. Biedermann, Blankenhain 99444, Germany
St.-Josefs-Hospital, Cloppenburg 49661, Germany
Praxis Dr. Pohl, Dresden 01129, Germany
Praxis KoĆler-Wiesweg, Essen 45138, Germany
Praxis Dr. Rƶvenich, Frankfurt 65929, Germany
Praxis Dr. Strzata, Kapellendorf 99510, Germany
Praxis Dr. Pitule, Ludwigshafen 67061, Germany
Praxis Dr. Loddo, Rastede, Niedersachsen 26180, Germany
Praxis Dr. Paschmionka, Leipzig, Sachsen 04316, Germany
Additional Information
Starting date: December 2011
Last updated: June 24, 2013
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