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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Cardiovascular Diseases
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Vascular Diseases
Olmesartan
Olmesartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014