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Completed

NCT Number: NCT00676845

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Up to 1 year of double-blind treatment

  2. 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

    Time frame: Up to 1 year of double-blind treatment

Secondary outcomes

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

    Time frame: Up to 1 year of double-blind treatment

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

    Time frame: Up to 1 year of double-blind treatment

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

    Time frame: Up to 1 year of double-blind 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 Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome

Acronym: ArtStiff

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 13, 2008
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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