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

Hypertension Clinical Trial

— ArtStiff  

Official title:

Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676845
• Other study ID #: DSE-866/47
• Secondary ID: 2007-003131-23 E
• Status: Completed
• Phase: Phase 3
• Start date: August 2008
• Est. completion date: May 2011

Study information

• Verified date: April 2012
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
• placebo
dosage form: tablet; frequency: daily; duration: 3 weeks
• olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
• olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Countries where clinical trial is conducted

Belgium,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in carotid-femoral pulse wave velocity (PWV)		Up to 1 year of double-blind treatment
Primary	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
Secondary	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
Secondary	On central pulse pressure (PP) and augmentation index (AI)		Up to 1 year of double-blind treatment
Secondary	On common carotid stiffness, intima-media thickness (IMT), and internal diameter		Up to 1 year of double-blind treatment