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

NCT01613209 | Completed Phase 3 DMC

• 1 other identifier: Sevicontrol-1
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 12

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.

Conditions

Hypertension

Keywords

Hypertension; ABPM; office blood pressure; olmesartan; amlodipine; fixed combination; time of intake

Outcome Measures

Primary Outcomes (2)

• Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).

  After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan

  after six and after 12 weeks

• change in systolic OBPM

  After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM.

  after 6 and after 12 weeks

Secondary Outcomes (6)

• change in diastolic OBPM

  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

• change in 24 hr mean values and diastolic day mean value

  after six and after 12 weeks

• 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

Study Arms (1)

Olmesartan/Amlodipin fixed combination

EXPERIMENTAL

Drug: Candesartan cilexetil; Drug: Olmesartan/Amlodipin

Interventions

Candesartan cilexetil DRUG

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

Olmesartan/Amlodipin fixed combination

Olmesartan/Amlodipin 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)

Also known as: Sevikar(r)

Olmesartan/Amlodipin fixed combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (12)

Praxis Dr. Loddo

Rastede, Lower Saxony, 26180, Germany

Location

Praxis Dr. Paschmionka

Leipzig, Saxony, 04316, Germany

Location

Praxis Dr. Reimer

Anderbeck, 38836, Germany

Location

Praxis Dr. Heinz

Bergisch Gladbach, 51429, Germany

Location

Praxis Dr. Zemmrich

Berlin, 12043, Germany

Location

Praxis Dr. Biedermann

Blankenhain, 99444, Germany

Location

St.-Josefs-Hospital

Cloppenburg, 49661, Germany

Location

Praxis Dr. Pohl

Dresden, 01129, Germany

Location

Praxis Koßler-Wiesweg

Essen, 45138, Germany

Location

Praxis Dr. Rövenich

Frankfurt, 65929, Germany

Location

Praxis Dr. Strzata

Kapellendorf, 99510, Germany

Location

Praxis Dr. Pitule

Ludwigshafen, 67061, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil; olmesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephan Lueders, Dr.med.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 7, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 3, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)