Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Candesartan cilexetil
* Drug: Olmesartan/Amlodipin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olmesartan/Amlodipin fixed combination<br> | Drug: Candesartan cilexetil<br>* candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,<br>Drug: Olmesartan/Amlodipin<br>* 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)<br>* Other names: Sevikar(r);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement). | After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan | after six and after 12 weeks | 
| change in systolic OBPM | After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM. | after 6 and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in diastolic OBPM | After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan | after six and after 12 weeks | 
| Change in systolic and diastolic ABPM night mean values | 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. | after 6 weeks therapy with fixed combination of olmesartan and amlodipine | 
| 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 | 
| Number of patients achieving target values for OBPM and ABPM |  | after six and after 12 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, ABPM, office blood pressure, olmesartan, amlodipine, fixed combination, time of intake