Trial | NCT01611077  Report issue

Title

Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    88
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.
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
Study Started
Jan 31
2012
Primary Completion
Dec 31
2012
Study Completion
Jan 31
2013
Last Update
Feb 23
2017

Drug Candesartan cilexetil

Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days

  • Other names: Atacand

Drug Olmesartan medoxomil

Switch to olmesartan 40 mg tablets once daily for 42 days,

  • Other names: Olmetec

Drug Olmesartan/amlodipine

then switch to olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days

  • Other names: Sevikar (r)

Single Arm Other

Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days, then olmesartan 40 mg tablets once daily for 42 days, then olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days

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
No Results Posted