Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine

NCT ID: NCT01613209

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-10-31

Brief Summary

The investigators want to find out whether a recently introduced combination of two blood pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering effect than a single active substance. In addition the investigators want to find out whether there is a difference in the changes in blood pressure over the course of a day depending on the time when the medications are taken (in the morning or at night). Male and female patients over 18 years of age may participate.

Detailed Description

Investigation of changes in blood pressure after six weeks therapy with a fixed combination of 40 mg olmesartan and 10 mg amlodipine compared to a monotherapy with 32 mg candesartan. Investigation of changes in dipping-profile after a further six weeks of therapy with the fixed combination when time of intake is switched from morning to evening.

Conditions

Hypertension

Study Design

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

Study Groups

Olmesartan/Amlodipin fixed combination

Group Type: EXPERIMENTAL

Candesartan cilexetil

Intervention Type: DRUG

candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,

Olmesartan/Amlodipin

Intervention Type: DRUG

olmesartan/amlodipine 40/5 mg tablets for 14 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 28 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 42 days (evening)

Interventions

Candesartan cilexetil

candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,

Intervention Type: DRUG

Olmesartan/Amlodipin

olmesartan/amlodipine 40/5 mg tablets for 14 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 28 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 42 days (evening)

Intervention Type: DRUG

Other Intervention Names

Sevikar(r)

Eligibility Criteria

Inclusion Criteria

• essential hypertension, i. e. systolic OPM >=140 mmHg at screening and >=160 mmHg after two weeks wash-out

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

• 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 Lueders, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus St.-Josef-Stift, Krankenhausstraße 13, D-49661 Cloppenburg

Locations

Praxis Dr. Loddo

Rastede, Lower Saxony, Germany

Praxis Dr. Paschmionka

Leipzig, Saxony, Germany

Praxis Dr. Reimer

Anderbeck, , Germany

Praxis Dr. Heinz

Bergisch Gladbach, , Germany

Praxis Dr. Zemmrich

Berlin, , Germany

Praxis Dr. Biedermann

Blankenhain, , Germany

St.-Josefs-Hospital

Cloppenburg, , Germany

Praxis Dr. Pohl

Dresden, , Germany

Praxis Koßler-Wiesweg

Essen, , Germany

Praxis Dr. Rövenich

Frankfurt, , Germany

Praxis Dr. Strzata

Kapellendorf, , Germany

Praxis Dr. Pitule

Ludwigshafen, , Germany

Countries

Germany

Other Identifiers

Sevicontrol-1

Identifier Type: -

Identifier Source: org_study_id