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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metabolic Syndrome; Hypertension

Intervention: olmesartan medoxomil (Drug); placebo (Drug); olmesartan medoxomil (Drug); olmesartan medoxomil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Europe, GmbH

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

The change from baseline in carotid-femoral pulse wave velocity (PWV)

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

Secondary outcome:

On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM)

On central pulse pressure (PP) and augmentation index (AI)

On common carotid stiffness, intima-media thickness (IMT), and internal diameter

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ghent, Belgium

Nurnberg, Germany

Monza, Italy

Additional Information

Starting date: August 2008
Last updated: April 26, 2012

Page last updated: August 20, 2015

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