Trial document




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  DRKS00003449

Trial Description

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Title

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

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Trial Acronym

Sevicontrol 2

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We 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.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00003449
  •   2012/01/05
  •   [---]*
  •   yes
  •   Approved
  •   18/2011, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  •   2011-004249-42 
  •   4037690 
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Health Condition or Problem studied

  •   I10.90 -  [generalization I10: Essential (primary) hypertension]
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Interventions/Observational Groups

  •   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
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values after six weeks therapy with a monotherapy with olmesartan 40 mg and further six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan. ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.

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Secondary Outcome

Change in systolic/diastolic office blood pressure and mean values (night-time and 24 h for systolic bp and day-time, night-time and 24 h for diastolic bp) after therapy change from candesartan to olmesartan 40 mg and then to a fixed combination of olmesartan 40 mg and amlodipine 10 mg.
Comparison of office bp and ABPM (long-term ambulatory blood pressure monitoring) measurements with regard to achieving the target bp values (<140/90 mmHg for OBPM; < 135/85 mmHg for mean day-time ABPM value). OBPM (office bp) and ABPM will be performed at the end of each treatment phase.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/01/09
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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 hghly 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

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Addresses

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    • IPPMed GmbH
    • Mr.  PD Dr. med.  Peter  Bramlage 
    • Menzelstraße 21
    • 15831  Mahlow
    • Germany
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    • IPPMed GmbH
    • Mr.  PD Dr. med.  Peter  Bramlage 
    • Menzelstraße 21
    • 15831  Mahlow
    • Germany
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    • St. Josephs-Hospital Cloppenburg
    • Mr.  Dr. med.  Stephan  Lüders 
    • Krankenhausstraße 13
    • 49661  Cloppenburg
    • Germany
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Sources of Monetary or Material Support

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    • Daiichi Sankyo Deutschland
    • 81379  München
    • Germany
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    •   [---]*
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/13
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Trial Publications, Results and other Documents

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