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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Europe, GmbH; Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Treatments: Olmesartan; Olmesartan Medoxomil

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