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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan cilexetil; Drug: Olmesartan/Amlodipin

• Registration Number: NCT01613209
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-07
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olmesartan/Amlodipin fixed combination	Olmesartan/Amlodipin	-
Olmesartan/Amlodipin fixed combination	Candesartan cilexetil	-

Primary Outcome Measures

Name	Time	Method
Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).	after six and after 12 weeks	After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan
change in systolic OBPM	after 6 and after 12 weeks	After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM.

Secondary Outcome Measures

Name	Time	Method
Distribution of patients over the four dipper types	after six and after 12 weeks
Number of patients achieving target values for OBPM and ABPM	after six and after 12 weeks
Change in systolic and diastolic ABPM night mean values	after 6 weeks therapy with fixed combination of olmesartan and amlodipine	first ABPM to be performed after 2 weeks wash-out followed by six weeks monotherapy with candesartan. Second ABPM to be performed after six weeks therapy with the fixed combination, given in the morning.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	From screening visit to end of follow-up, up to 20 weeks
change in diastolic OBPM	after six and after 12 weeks	After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan
change in 24 hr mean values and diastolic day mean value	after six and after 12 weeks

Trial Locations

Locations (12)

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

Praxis Dr. Pohl; 🇩🇪 Dresden, Germany

Praxis Dr. Reimer; 🇩🇪 Anderbeck, Germany

Praxis Dr. Loddo; 🇩🇪 Rastede, Niedersachsen, Germany

Praxis Dr. Zemmrich; 🇩🇪 Berlin, Germany

Praxis Koßler-Wiesweg; 🇩🇪 Essen, Germany

Praxis Dr. Strzata; 🇩🇪 Kapellendorf, Germany

Praxis Dr. Paschmionka; 🇩🇪 Leipzig, Sachsen, Germany

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

Praxis Dr. Biedermann; 🇩🇪 Blankenhain, Germany

Praxis Dr. Pitule; 🇩🇪 Ludwigshafen, Germany

Praxis Dr. Rövenich; 🇩🇪 Frankfurt, Germany