Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome (VAMOS)

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Hypertension; Metabolic Syndrome

Treatments: Drug: Amlodipine; Drug: Olmesartan medoxomil tablets low dose; Drug: Olmesartan medoxomil tablets high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00891267

DSE-866/46

2007-003130-41 EudraCT number

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Olmesartan medoxomil low dose

Experimental group

Description:

Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks

Treatment:

Drug: Olmesartan medoxomil tablets low dose

Olmesartan medoxomil tablets high dose

Experimental group

Description:

Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks

Treatment:

Drug: Olmesartan medoxomil tablets high dose

Amlodipine

Active Comparator group

Description:

Amlodipine taken once daily for 6 weeks

Treatment:

Drug: Amlodipine