Effect of Olmesartan Medoxomil on arterial stiffness and thickness in subjects with metabolic syndrome.

Phase 3

Completed

Conditions: arterial stiffness and thickness
hypertension
10057166

Registration Number: NL-OMON35439

Lead Sponsor: Daiichi Sankyo Europe

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Age >= 18 and <= 75 years
- Hypertension and metabolic syndrome defined, according to the ATP III/ IDF 2005 and ESH/ESC 2007 definitions with modifications;
see Amended Protocol Version NL-1.0 page 25

Exclusion Criteria

- Pregnant or lactating female;
- Type 1 and type 2 diabetes;
- *High range* mild hypertension;
- Moderate, severe, or resistant hypertension;
- Secondary hypertension of any aetiology;
- Kidney function impairment;
see protocol page 25 + see Substantial Amendment 1, page 6 of 9 + Substantial Amendment the Netherlands-specific 1, page 5 of 7 + Amended Protocol Version NL-1.0 page 26

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>to investigate in a descriptive way the dose-dependent effect of Olmesartan<br /><br>Medoxomil 20mg, 40mg and 80mg on arterial stiffness assessed by:<br /><br>• The change from baseline in carotid-femoral Pulse Wave Velocity (PWV) after<br /><br>52 weeks of double-blind treatment<br /><br>• The change from baseline in carotid-femoral PWV, after adjustment for change<br /><br>from baseline in Mean Blood Pressure (MBP) after 52 weeks of double-blind<br /><br>treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate in a descriptive way the dose-dependent effect of Olmesartan<br /><br>Medoxomil 20mg, 40mg and 80mg:<br /><br>• The change from baseline in carotid-femoral Pulse Wave Velocity (PWV) after<br /><br>24 weeks of double-blind treatment<br /><br>• The change from baseline in carotid-femoral PWV, after adjustment for change<br /><br>from baseline in Mean Blood Pressure (MBP) after 24 weeks of double-blind<br /><br>treatment<br /><br>• On Blood Pressure (BP) lowering, assessed by conventional BP measurement and<br /><br>24h Ambulatory BP Measurement (24h-ABPM) after 52 and 24 weeks of double-blind<br /><br>treatment<br /><br>• On central Pulse Pressure (PP) and Augmentation Index (AI) after 52 and 24<br /><br>weeks of double-blind treatment<br /><br>• On common carotid stiffness, Intima-Media Thickness (IMT), and internal<br /><br>diameter after 52 and 24 weeks of double-blind treatment.</p><br>