Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection

Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00676845

Acronym

ArtStiff

Enrollment

133

Registered

2008-05-13

Start date

2008-08-31

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

Arterial stiffness, Vascular protection

Brief summary

This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in arterial stiffness in subjects with hypertension and metabolic syndrome

Interventions

DRUGolmesartan medoxomil

dosage form: oral tablet; frequency: daily; duration: 52 weeks

DRUGplacebo

dosage form: tablet; frequency: daily; duration: 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male and female outpatients * Age greater than or equal to 18 years and less than or equal to 75 years * Hypertension and metabolic syndrome defined, according to the ATP III/IDF 2005 and ESH/ESC 2007 definitions, as BP greater than or equal to 130/85 mmHg and \<150/95 mmHg (i.e. untreated high normal BP or low range mild hypertension) and at least 2 of the following traits at: * Abdominal obesity (waist circumference \>102 cm for men and \>88 cm for women) * Triglyceride level greater than or equal to 150 mg/dL * High density lipoprotein (HDL) \<40 mg/dL for men and \<50 mg/dL for women * Fasting blood glucose greater than or equal to 110 mg/dL and \<126 mg/dL (i.e. no type 2 diabetes) * No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months. Note: treatment with angiotensin II receptor blockers (ARB)or angiotensin-converting enzyme inhibitors (ACE) is not allowed within the last 6 months.

Exclusion criteria

* Pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception) * Type 1 and type 2 diabetes * High range mild hypertension (i.e. systolic blood pressure \[SBP\]: 150 - \<160 mmHg and /or diastolic blood pressure \[DBP\]: 95 - \<100 mmHg) * Moderate (SBP: 160 - 179 mmHg and DBP: 100 - 109 mmHg), severe (SBP: greater than or equal to 180 mmHg and/or greater than or equal to 110 mmHg), or resistant (hypertension resistant to treatment)hypertension * Secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome

Design outcomes

Primary

Measure	Time frame
The change from baseline in carotid-femoral pulse wave velocity (PWV)	Up to 1 year of double-blind treatment
The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in mean blood pressure (MBP)as measured at the same visit	Up to 1 year of double-blind treatment

Secondary

Measure	Time frame
On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM)	Up to 1 year of double-blind treatment
On central pulse pressure (PP) and augmentation index (AI)	Up to 1 year of double-blind treatment
On common carotid stiffness, intima-media thickness (IMT), and internal diameter	Up to 1 year of double-blind treatment

Countries

Belgium, Germany, Italy

Outcome results

None listed

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