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

Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00891267

Acronym

VAMOS

Enrollment

Registered

2009-05-01

Start date

2008-10-31

Completion date

2011-05-31

Last updated

2018-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Metabolic Syndrome

Keywords

Inflammatory markers, Vascular protection, OM Effect, Metabolic syndrome, Hypertension

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.

Interventions

DRUGOlmesartan medoxomil tablets low dose

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

DRUGOlmesartan medoxomil tablets high dose

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

DRUGAmlodipine

Amlodipine tablets taken once daily for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
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	6 weeks for each treatment

Secondary

Measure	Time frame
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)	6 weeks for each treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026