DSE-866/47
Research type
Research Study
Full title
EFFECT OF OLMESARTAN MEDOXOMIL ON ARTERIAL STIFFNESS AND THICKNESS IN SUBJECTS WITH METABOLIC SYNDROME
Sponsor organisation
Wales Heart Research Institute - University Hospital
Eudract number
2007-003131-23
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
The drug studied in this clinical study, belongs to the class of drugs referred to as angiotensin II receptor antagonists. In our body, blood Pressure is controlled by several substances. One of these substances reduces the size of our blood vessels and is called angiotensin II. This reduction in blood vessel size causes an increase in blood Pressure. Study drug works by blocking the effect of angiotensin II, thereby lowering blood Pressure. Other clinical studies have shown that the study drug may have the potential to benefit the cardiovascular system by protecting the blood vessels. Therefore, the purpose of this study is to investigate the effect of three different doses OM on the stiffness of the blood vessels and other characteristics of the blood vessels. In this study, approximately 318 patients in 6 countries will be enrolled in approximately 40 European investigative sites. In UK, these sites are located in Cambridge and Cardiff. The study is divided in 2 periods: a screening and a treatment period. During the 3-week screening period, the patient will take run-in medication (one tablet once a day in the morning). During the 52-week treatment period, the patient will either receive 20mg, 40mg or 80 mg of the study drug (three tablets once a day). Patients will be involved in this clinical study for a maximum of 57 weeks. During this period, they will need to visit their doctor 8 times, and if needed, one extra visit may be performed as a Safety Follow-up. At 3 occasions, they also need to visit the ECHO-centre (a specialized medical centre, where echographic measurements will be performed and the device called an Ambulatory Blood Pressure Monitoring device will be provided).
REC name
London - Central Research Ethics Committee
REC reference
08/H0718/74
Date of REC Opinion
4 Feb 2009
REC opinion
Further Information Favourable Opinion