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

NCT ID: NCT01611077

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-01-31

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

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Candesartan cilexetil

Intervention Type: DRUG

Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days

Olmesartan medoxomil

Intervention Type: DRUG

Switch to olmesartan 40 mg tablets once daily for 42 days,

Olmesartan/amlodipine

Intervention Type: DRUG

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

Interventions

Candesartan cilexetil

Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days

Intervention Type: DRUG

Olmesartan medoxomil

Switch to olmesartan 40 mg tablets once daily for 42 days,

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Atacand; Olmetec; Sevikar (r)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut für Pharmakologie und Präventive Medizin

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Lüders, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

St.-Josefs-Hospital Cloppenburg

Locations

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

Countries

Germany

Other Identifiers

Sevicontrol-2

Identifier Type: -

Identifier Source: org_study_id