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

NCT01611077 — Phase 4, Completed, 88 participants, Institut für Pharmakologie und Präventive Medizin

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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

Registry	NCT01611077, acronym Sevicontrol-2
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	88 (Actual)
Sponsor	Institut für Pharmakologie und Präventive Medizin (Network)
Conditions	Hypertension
Interventions	Candesartan cilexetil, Olmesartan medoxomil, Olmesartan/amlodipine (Drug)
Dates	start 2012-01-01, primary completion 2012-12-01, completion 2013-01-01, first posted 2012-06-04, last updated 2017-02-23
Locations	11 sites in Germany

-Summary

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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Single Arm	Other	Drug: Candesartan cilexetil; Drug: Olmesartan medoxomil; Drug: Olmesartan/amlodipine	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

Candesartan cilexetil (Drug), also known as Atacand: Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days
Olmesartan medoxomil (Drug), also known as Olmetec: Switch to olmesartan 40 mg tablets once daily for 42 days,
Olmesartan/amlodipine (Drug), also known as Sevikar (r): 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

+Outcome measures

Primary outcomes

Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values [ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.]: 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 outcomes

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) [after 6 and 12 weeks]: from candesartan to olmesartan 40 mg and then to a fixed combination of olmesartan 40 mg and amlodipine 10 mg.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (11)

Facility	City	Country
Praxis Dr. Reimer	Anderbeck	Germany
Praxis Dr. Heinz	Bergisch Gladbach	Germany
Praxis Dr. Zemmrich	Berlin	Germany
St.-Josefs-Hospital	Cloppenburg	Germany
Praxis Dr. Pohl	Dresden	Germany
Praxis Dr. Koßler-Wiesweg	Essen	Germany
Praxis Dr. Rövenich	Frankfurt	Germany
Praxis Dr. Strzata	Kapellendorf	Germany
Praxis Dr. Paschmionka	Leipzig	Germany
Praxis Dr. Pitule	Ludwigshafen	Germany
Praxis Dr. Loddo	Rastede	Germany

+Investigators

Stephan Lüders, Dr.med., Principal investigator, St.-Josefs-Hospital Cloppenburg