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
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Candesartan cilexetil
Drug: Olmesartan medoxomil
Drug: Olmesartan/amlodipine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institut für Pharmakologie und Präventive Medizin:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 88
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611077

Locations
Germany
Praxis Dr. Reimer
Anderbeck, Germany, 38836
Praxis Dr. Heinz
Bergisch-Gladbach, Germany, 51429
Praxis Dr. Zemmrich
Berlin, Germany, 12043
St.-Josefs-Hospital
Cloppenburg, Germany, 49661
Praxis Dr. Pohl
Dresden, Germany, 01129
Praxis Dr. Koßler-Wiesweg
Essen, Germany, 45138
Praxis Dr. Rövenich
Frankfurt, Germany, 65929
Praxis Dr. Strzata
Kapellendorf, Germany, 99510
Praxis Dr. Paschmionka
Leipzig, Germany, 04316
Praxis Dr. Pitule
Ludwigshafen, Germany, 67061
Praxis Dr. Loddo
Rastede, Germany, 26180
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Investigators
Principal Investigator: Stephan Lüders, Dr.med. St.-Josefs-Hospital Cloppenburg
  More Information

No publications provided

Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT01611077     History of Changes
Other Study ID Numbers: Sevicontrol-2
Study First Received: May 30, 2012
Last Updated: June 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Candesartan cilexetil
Candesartan
Olmesartan medoxomil
Olmesartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 23, 2014