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
|