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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH )
ClinicalTrials.gov Identifier:
NCT00676845
First received: May 8, 2008
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Metabolic Syndrome
Hypertension
Drug: olmesartan medoxomil
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • The change from baseline in carotid-femoral pulse wave velocity (PWV) [ Time Frame: Up to 1 year of double-blind treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • On central pulse pressure (PP) and augmentation index (AI) [ Time Frame: Up to 1 year of double-blind treatment ] [ Designated as safety issue: No ]
  • On common carotid stiffness, intima-media thickness (IMT), and internal diameter [ Time Frame: Up to 1 year of double-blind treatment ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: August 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
A 3-week placebo run-in period.
Drug: placebo
dosage form: tablet; frequency: daily; duration: 3 weeks
Experimental: 2
Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period
Drug: olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
Experimental: 3
Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks.
Drug: olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
Experimental: 4
Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 4 weeks followed by the highest study dose for 44 weeks.
Drug: olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676845

Locations
Belgium
Ghent, Belgium
Germany
Nurnberg, Germany
Italy
Monza, Italy
Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH )
ClinicalTrials.gov Identifier: NCT00676845     History of Changes
Other Study ID Numbers: DSE-866/47, 2007-003131-23 EudraCT number
Study First Received: May 8, 2008
Last Updated: April 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Daiichi Sankyo Inc.:
Arterial stiffness
Vascular protection

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Olmesartan medoxomil
Olmesartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014