Clinical trial NCT01613209: Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
ABPM
office blood pressure
olmesartan
amlodipine
fixed combination
time of intake
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2012-06-07
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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 (\>= 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

Primary outcomes:
measure: Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).
timeFrame: after six and after 12 weeks
measure: change in systolic OBPM
timeFrame: after 6 and after 12 weeks
Secondary outcomes:
measure: change in diastolic OBPM
timeFrame: after six and after 12 weeks
measure: Change in systolic and diastolic ABPM night mean values
timeFrame: after 6 weeks therapy with fixed combination of olmesartan and amlodipine
measure: change in 24 hr mean values and diastolic day mean value
timeFrame: after six and after 12 weeks
measure: Distribution of patients over the four dipper types
timeFrame: after six and after 12 weeks
measure: Number of patients achieving target values for OBPM and ABPM
timeFrame: after six and after 12 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: From screening visit to end of follow-up, up to 20 weeks
Other outcomes:
Locations:
city: Rastede
country: Germany
facility: Praxis Dr. Loddo
state: Niedersachsen
city: Leipzig
country: Germany
facility: Praxis Dr. Paschmionka
state: Sachsen
city: Anderbeck
country: Germany
facility: Praxis Dr. Reimer
city: Bergisch-Gladbach
country: Germany
facility: Praxis Dr. Heinz
city: Berlin
country: Germany
facility: Praxis Dr. Zemmrich
city: Blankenhain
country: Germany
facility: Praxis Dr. Biedermann
city: Cloppenburg
country: Germany
facility: St.-Josefs-Hospital
city: Dresden
country: Germany
facility: Praxis Dr. Pohl
city: Essen
country: Germany
facility: Praxis Koßler-Wiesweg
city: Frankfurt
country: Germany
facility: Praxis Dr. Rövenich
city: Kapellendorf
country: Germany
facility: Praxis Dr. Strzata
city: Ludwigshafen
country: Germany
facility: Praxis Dr. Pitule
Study officials:
affiliation: Krankenhaus St.-Josef-Stift, Krankenhausstraße 13, D-49661 Cloppenburg
name: Stephan Lueders, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: