NCT00982501

WS®1442 in Slightly Overweight Subjects

Investigation of Safety of WS®1442 in Slightly Overweight Subjects With Pilot Assessment of Pharmacodynamic Effects of WS®1442 on Endothelial Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dr. Willmar Schwabe GmbH & Co. KG · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test: 1. Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²) 2. Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects

Detailed description

60 overweight subjects with a BMI of 25 to 29,9 kg/m2 are to be included. The safety of 900 mg/1800 mg per day WS® 1442 is determined by adverse events, laboratory parameters, vital signs as well as by a treadmill test at the beginning and the end of the study. Endothelial function measured before and after two different training modalities is compared to that measured before and after intake of two different doses of WS® 1442.

Conditions

• Overweight

Interventions

Type	Name	Description
DRUG	WS® 1442 900 mg/d
DRUG	WS® 1442 1800 mg/d
BEHAVIORAL	Nordic walking training 2 x 30 min/week
BEHAVIORAL	Nordic walking training 4x45 min/week

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-09-01
• Completion: 2011-02-01
• First posted: 2009-09-23
• Last updated: 2014-05-14

Locations

1 site across 1 country: Austria