Status:
COMPLETED
Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Lead Sponsor:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Conditions:
Metabolic Syndrome
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.
Eligibility Criteria
Inclusion
- Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
- Blood pressure greater than or equal to 130/85 mmHg AND
- hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
- abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
- triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women
- fasting blood glucose greater than or equal to 110mg/dL
Exclusion
- Insulin depended diabetes or type-1 diabetes
- Severe or resistant hypertension
- Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, 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)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00891267
Start Date
October 1 2008
End Date
May 1 2011
Last Update
December 24 2018
Active Locations (1)
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1
Erlangen, Germany