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Trial record 10 of 139 for:    OLMESARTAN

Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine (Sevicontrol1)

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ClinicalTrials.gov Identifier: NCT01613209
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Tracking Information
First Submitted Date  ICMJE May 30, 2012
First Posted Date  ICMJE June 7, 2012
Last Update Posted Date May 3, 2016
Study Start Date  ICMJE December 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
  • Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement). [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01613209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
  • change in diastolic OBPM [ Time Frame: 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 and diastolic ABPM night mean values [ Time Frame: 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.
  • change in 24 hr mean values and diastolic day mean value [ Time Frame: after six and after 12 weeks ]
  • Distribution of patients over the four dipper types [ Time Frame: after six and after 12 weeks ]
  • Number of patients achieving target values for OBPM and ABPM [ Time Frame: after six and after 12 weeks ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From screening visit to end of follow-up, up to 20 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Candesartan cilexetil
    candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,
  • Drug: Olmesartan/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)
    Other Name: Sevikar(r)
Study Arms  ICMJE Experimental: Olmesartan/Amlodipin fixed combination
Interventions:
  • Drug: Candesartan cilexetil
  • Drug: Olmesartan/Amlodipin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2013)
83
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2012)
81
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01613209
Other Study ID Numbers  ICMJE Sevicontrol-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut für Pharmakologie und Präventive Medizin
Study Sponsor  ICMJE Institut für Pharmakologie und Präventive Medizin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephan Lueders, Dr.med. Krankenhaus St.-Josef-Stift, Krankenhausstraße 13, D-49661 Cloppenburg
PRS Account Institut für Pharmakologie und Präventive Medizin
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP