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

Information source: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Candesartan cilexetil (Drug); Olmesartan/Amlodipin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Institut für Pharmakologie und Präventive Medizin

Official(s) and/or principal investigator(s):
Stephan Lueders, Dr.med., Principal Investigator, Affiliation: Krankenhaus St.-Josef-Stift, KrankenhausstraƟe 13, D-49661 Cloppenburg

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.

Clinical Details

Official title: Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan 40 mg / Amlodipine 10 mg in Patients With Insufficiently Controlled Hypertension Under Monotherapy With Candesartan 32 mg - an Open Phase IIIb Trial

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

change in systolic OBPM

Secondary outcome:

change in diastolic OBPM

Change in systolic and diastolic ABPM night mean values

change in 24 hr mean values and diastolic day mean value

Distribution of patients over the four dipper types

Number of patients achieving target values for OBPM and ABPM

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 (>= IIĀ°) 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

Locations and Contacts

Praxis Dr. Reimer, Anderbeck 38836, Germany

Praxis Dr. Heinz, Bergisch-Gladbach 51429, Germany

Praxis Dr. Zemmrich, Berlin 12043, Germany

Praxis Dr. Biedermann, Blankenhain 99444, Germany

St.-Josefs-Hospital, Cloppenburg 49661, Germany

Praxis Dr. Pohl, Dresden 01129, Germany

Praxis KoƟler-Wiesweg, Essen 45138, Germany

Praxis Dr. Rƶvenich, Frankfurt 65929, Germany

Praxis Dr. Strzata, Kapellendorf 99510, Germany

Praxis Dr. Pitule, Ludwigshafen 67061, Germany

Praxis Dr. Loddo, Rastede, Niedersachsen 26180, Germany

Praxis Dr. Paschmionka, Leipzig, Sachsen 04316, Germany

Additional Information

Starting date: December 2011
Last updated: June 24, 2013

Page last updated: August 20, 2015

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