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

Phase 3

Completed

• Conditions: Hypertension; Metabolic Syndrome
• Interventions: Drug: placebo; Drug: olmesartan medoxomil

• Registration Number: NCT00676845
• Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-13
• Study Start: 2008-08
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-04
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	A 3-week placebo run-in period.
2	olmesartan medoxomil	Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period
3	olmesartan medoxomil	Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks.
4	olmesartan medoxomil	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.

Primary Outcome Measures

Name	Time	Method
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	Up to 1 year of double-blind treatment
The change from baseline in carotid-femoral pulse wave velocity (PWV)	Up to 1 year of double-blind treatment

Secondary Outcome Measures

Name	Time	Method
On common carotid stiffness, intima-media thickness (IMT), and internal diameter	Up to 1 year of double-blind treatment
On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM)	Up to 1 year of double-blind treatment
On central pulse pressure (PP) and augmentation index (AI)	Up to 1 year of double-blind treatment