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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier:
NCT01613209
First received: May 30, 2012
Last updated: June 24, 2013
Last verified: June 2013

May 30, 2012
June 24, 2013
December 2011
September 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM.
Same as current
Complete list of historical versions of study NCT01613209 on ClinicalTrials.gov Archive Site
  • change in diastolic OBPM [ Time Frame: after six and after 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Distribution of patients over the four dipper types [ Time Frame: after six and after 12 weeks ] [ Designated as safety issue: No ]
  • Number of patients achieving target values for OBPM and ABPM [ Time Frame: after six and after 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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)
Experimental: Olmesartan/Amlodipin fixed combination
Interventions:
  • Drug: Candesartan cilexetil
  • Drug: Olmesartan/Amlodipin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
October 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01613209
Sevicontrol-1
Yes
Institut für Pharmakologie und Präventive Medizin
Institut für Pharmakologie und Präventive Medizin
Not Provided
Principal Investigator: Stephan Lueders, Dr.med. Krankenhaus St.-Josef-Stift, Krankenhausstraße 13, D-49661 Cloppenburg
Institut für Pharmakologie und Präventive Medizin
June 2013

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