Clinical trial NCT01611077: Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg
Official title: Efficacy and Safety of a Sequential Therapy Change From Candesartan 32 mg to the Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg in Patients With Poorly Controlled Moderate Hypertension - an Open Phase IV Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2012-06-04
Enrollment: 88
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 if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve comparable baseline conditions. Treatment is then started with the single substance. After six weeks, therapy is changed to another single substance and after a further six weeks, to the fixed combination tablet. Blood pressure is determined by office measurements taken by the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be male or female and must be over 18 years of age.

Detailed description: SEVICONTROL-2:

Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial

Eligibility criteria: Inclusion Criteria:

* male or female patients \>= 18 years of age
* essential hypertension, i. e. systolic office bp \>= 140 mmHg for pre-treated patients or \>= 160 mmHg for untreated patients at screening visit and \>= 160 mmHg at end of wash-out
* signed IC

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
* parallel participation in other clinical trials

Primary outcomes:
measure: Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values
timeFrame: ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.
Secondary outcomes:
measure: Change in systolic/diastolic office blood pressure and mean values (night-time and 24 hr for systolic bp and day-time, night-time and 24 hr for diastolic bp)
timeFrame: after 6 and 12 weeks
Other outcomes:
Locations:
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: Cloppenburg
country: Germany
facility: St.-Josefs-Hospital
city: Dresden
country: Germany
facility: Praxis Dr. Pohl
city: Essen
country: Germany
facility: Praxis Dr. Koßler-Wiesweg
city: Frankfurt
country: Germany
facility: Praxis Dr. Rövenich
city: Kapellendorf
country: Germany
facility: Praxis Dr. Strzata
city: Leipzig
country: Germany
facility: Praxis Dr. Paschmionka
city: Ludwigshafen
country: Germany
facility: Praxis Dr. Pitule
city: Rastede
country: Germany
facility: Praxis Dr. Loddo
Study officials:
affiliation: St.-Josefs-Hospital Cloppenburg
name: Stephan Lüders, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: