Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg (Sevicontrol-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier:
NCT01611077
First received: May 30, 2012
Last updated: June 24, 2013
Last verified: June 2013

May 30, 2012
June 24, 2013
January 2012
December 2012   (final data collection date for primary outcome measure)
Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values [ Time Frame: ABPM will be performed after 6 weeks treatment with each of the different therapy regimes. ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01611077 on ClinicalTrials.gov Archive Site
Change in systolic/diastolic office blood pressure and mean values (night-time and 24 hr for systolic bp and day-time, night-time and 24 hr for diastolic bp) [ Time Frame: after 6 and 12 weeks ] [ Designated as safety issue: No ]
from candesartan to olmesartan 40 mg and then to a fixed combination of olmesartan 40 mg and amlodipine 10 mg.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg
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

The investigators 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.

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

Interventional
Phase 4
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. once daily for 14 days, 32 mg tablets once daily for 28 days
  • Drug: Olmesartan medoxomil
    Switch to olmesartan 40 mg tablets once daily for 42 days,
  • Drug: Olmesartan/amlodipine
    then switch to olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days
    Other Name: Sevikar (r)
Single Arm
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
Interventions:
  • Drug: Candesartan cilexetil
  • Drug: Olmesartan medoxomil
  • Drug: Olmesartan/amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
January 2013
December 2012   (final data collection date for primary outcome measure)

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

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
  • parallel participation in other clinical trials
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01611077
Sevicontrol-2
Yes
Institut für Pharmakologie und Präventive Medizin
Institut für Pharmakologie und Präventive Medizin
Not Provided
Principal Investigator: Stephan Lüders, Dr.med. St.-Josefs-Hospital 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