Status:
COMPLETED
Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection
Lead Sponsor:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Conditions:
Metabolic Syndrome
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00676845
Start Date
August 1 2008
End Date
May 1 2011
Last Update
December 24 2018
Active Locations (3)
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1
Ghent, Belgium
2
Nuremberg, Germany
3
Monza, Italy