Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg - Full Text View

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Candesartan Olmesartan Olmesartan medoxomil Candesartan cilexetil

U.S. FDA Resources

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.

Estimated Enrollment:	80
Study Start Date:	January 2012
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	October 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)

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

Contacts

Contact: Peter Bramlage, Dr.med.

+4933793147890

peter.bramlage@ippmed.de

Locations

Germany
Praxis Dr. Reimer	Recruiting
Anderbeck, Germany, 38836
Contact: Cornelia Reimer, Dr.med. +4939422449
Principal Investigator: Cornelia Reimer, Dr.med.
Praxis Dr. Heinz	Recruiting
Bergisch-Gladbach, Germany, 51429
Contact: Gerd-Ulrich Heinz, Dr.med. +492204911010
Principal Investigator: Gerd-Ulrich Heinz, Dr.med.
Praxis Dr. Zemmrich	Recruiting
Berlin, Germany, 12043
Contact: Claudia Zemmrich, Dr.med. +491787152405
Principal Investigator: Claudia Zemmrich, Dr.med.
St.-Josefs-Hospital	Recruiting
Cloppenburg, Germany, 49661
Contact: Stephan Lüders, Dr.med +494471161930 s.lueders@khclp.de
Principal Investigator: Stephan Lüders, Dr.med.
Praxis Dr. Pohl	Recruiting
Dresden, Germany, 01129
Contact: Wilgard Pohl, Dr.med. +493518014052
Principal Investigator: Wilgard Pohl, Dr.med.
Praxis Dr. Koßler-Wiesweg	Not yet recruiting
Essen, Germany, 45138
Contact: Christine Koßler-Wiesweg, Dr.med. +49201282008
Principal Investigator: Bernd Wiedeking, Dr.med.
Praxis Dr. Rövenich	Recruiting
Frankfurt, Germany, 65929
Contact: Matthias Rövenich, Dr.med. +4969302308
Principal Investigator: Matthias Rövenich, Dr.med.
Praxis Dr. Strzata	Recruiting
Kapellendorf, Germany, 99510
Contact: Norbert Strzata, Dr.med. +493642553535
Principal Investigator: Norbert Strzata, Dr.med
Praxis Dr. Paschmionka	Recruiting
Leipzig, Germany, 04316
Contact: Rita Paschmionka, Dr.med. +493416517149
Principal Investigator: Rita Paschmionka, Dr.med.
Praxis Dr. Pitule	Recruiting
Ludwigshafen, Germany, 67061
Contact: Hannelore Pitule, Dr.med. +49621571317
Principal Investigator: Hannelore Pitule, Dr.med.
Praxis Dr. Loddo	Recruiting
Rastede, Germany, 26180
Contact: Marco Loddo, Dr.med. +4944022532
Principal Investigator: Marco Loddo, Dr.med.

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:	May 31, 2012
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 June 17, 2013

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