Erlangen, Germany
NCT Number: NCT00891267
Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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)
Treatment and study plan
Olmesartan medoxomil tablets low dose
DrugOlmesartan medoxomil tablets low dose, taken once daily for 6 weeks
Olmesartan medoxomil tablets high dose
DrugOlmesartan medoxomil tablets high dose, taken once daily for 6 weeks
Amlodipine
DrugAmlodipine tablets taken once daily for 6 weeks
Primary outcomes
-
To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP
Time frame: 6 weeks for each treatment
Secondary outcomes
-
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)
Time frame: 6 weeks for each treatment
Sponsors and collaborators
Lead sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Industry
Registry information
Official study title
Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Acronym: VAMOS
Important dates
- Study start
- 2008
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- May 1, 2009
- Registry last updated
- Dec 24, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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