Metabolic Syndrome Hypertension MedDRA version: 9.1 Level: LLT Classification code 10052066 Term: Metabolic syndrome MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Sponsors
DAIICHI-SANKYO EUROPE GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation. At baseline, patients must have: • Blood pressure = 130/85 mmHg or drug treatment for hypertension, AND • hs-CRP = 1.0 and 102 cm for men and > 88 cm for women; • triglyceride level = 150 mg/dL or drug treatment for elevated TG; • HDL =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Insulin depended diabetes or type-1 diabetes; • Severe or resistant hypertension; • Patients with secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushing’s syndrome; • Any acute or chronic inflammatory disease; • Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start; • Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception); • Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s), including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic (criteria for metabolic syndrome see above), hematological or oncological, neurological and psychiatric diseases; • Patients having a history of the following within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, stroke or transient ischemic attack; • Patients with clinically significant abnormal laboratory values at screening and baseline; • Patients with contraindication to olmesartan medoxomil or amlodipine besilate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the anti-inflammatory effect of OM 80 mg compared to OM 20 mg and amlodipine (AML) 5 mg on the change in levels of the inflammatory marker hs-CRP.;Secondary Objective: • To evaluate the additional antihypertensive efficacy in blood pressure (BP) lowering, assessed by conventional BP measurement and 24-h ambulatory BP measurement (24-h ABPM). • To evaluate the effect on albumin excretion / microalbuminuria. • To evaluate the effect on other inflammatory markers: TNF-alpha, IL-6, as well as on plasma 8-isoprostane 15(S)-8-iso-prostaglandin F2a concentration for oxidative stress. • To evaluate the effect on insulin resistance: Adiponectin, HbA1c, and HOMA model. • To evaluate the effect on augmentation index and pulse wave velocity as assessed with the Sphygmocor device. • To evaluate the safety and tolerability of OM and amlodipine. ;Primary end point(s): Change in levels of the inflammatory marker hs-CRP after 6 weeks of double-blind treatment. | — |
Countries
Germany
Outcome results
None listed