Hypertension
Conditions
Keywords
Hypertension, ABPM, office blood pressure, olmesartan, amlodipine, fixed combination, time of intake
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.
Interventions
DRUGCandesartan cilexetil
candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,
DRUGOlmesartan/Amlodipin
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)
Sponsors
Institut für Pharmakologie und Präventive Medizin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement). | after six and after 12 weeks | After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan |
| change in systolic OBPM | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in 24 hr mean values and diastolic day mean value | after six and after 12 weeks | — |
| Distribution of patients over the four dipper types | after six and after 12 weeks | — |
| change in diastolic OBPM | after six and after 12 weeks | After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | From screening visit to end of follow-up, up to 20 weeks | — |
| Number of patients achieving target values for OBPM and ABPM | after six and after 12 weeks | — |
| Change in systolic and diastolic ABPM night mean values | after 6 weeks therapy with fixed combination of olmesartan and amlodipine | 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. |
Countries
Germany
Outcome results
None listed