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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan cilexetil; Drug: Olmesartan medoxomil; Drug: Olmesartan/amlodipine

• Registration Number: NCT01611077
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

Brief 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.

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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Olmesartan medoxomil	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
Single Arm	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
Single Arm	Candesartan cilexetil	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (11)

Praxis Dr. Reimer; 🇩🇪 Anderbeck, Germany

Praxis Dr. Zemmrich; 🇩🇪 Berlin, Germany

St.-Josefs-Hospital; 🇩🇪 Cloppenburg, Germany

Praxis Dr. Pohl; 🇩🇪 Dresden, Germany

Praxis Dr. Rövenich; 🇩🇪 Frankfurt, Germany

Praxis Dr. Koßler-Wiesweg; 🇩🇪 Essen, Germany

Praxis Dr. Pitule; 🇩🇪 Ludwigshafen, Germany

Praxis Dr. Strzata; 🇩🇪 Kapellendorf, Germany

Praxis Dr. Paschmionka; 🇩🇪 Leipzig, Germany

Praxis Dr. Loddo; 🇩🇪 Rastede, Germany

Praxis Dr. Heinz; 🇩🇪 Bergisch-Gladbach, Germany