Clinical trial NCT00676845: Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection
Official title: Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Hypertension
Keywords: Arterial stiffness
Vascular protection
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: The change from baseline in carotid-femoral pulse wave velocity (PWV)
timeFrame: Up to 1 year of double-blind treatment
measure: 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
timeFrame: Up to 1 year of double-blind treatment
Secondary outcomes:
measure: On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM)
timeFrame: Up to 1 year of double-blind treatment
measure: On central pulse pressure (PP) and augmentation index (AI)
timeFrame: Up to 1 year of double-blind treatment
measure: On common carotid stiffness, intima-media thickness (IMT), and internal diameter
timeFrame: Up to 1 year of double-blind treatment
Other outcomes:
Locations:
city: Ghent
country: Belgium
city: Nurnberg
country: Germany
city: Monza
country: Italy
Study officials:
References:
citation: Laurent S, Boutouyrie P; Vascular Mechanism Collaboration. Dose-dependent arterial destiffening and inward remodeling after olmesartan in hypertensives with metabolic syndrome. Hypertension. 2014 Oct;64(4):709-16. doi: 10.1161/HYPERTENSIONAHA.114.03282. Epub 2014 Jul 7.