Status:
COMPLETED
WS®1442 in Slightly Overweight Subjects
Lead Sponsor:
Dr. Willmar Schwabe GmbH & Co. KG
Conditions:
Overweight
Eligibility:
All Genders
45-75 years
Phase:
PHASE1
Brief 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 ve...
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 b...
Eligibility Criteria
Inclusion
- written informed consent
- male and female subjects aged 45-75 years
- untrained
- BMI between 25 and 29,9 kg/m²
- resting blood pressure in sitting position ≤ 140/90 mmHg
- inconspicuous ergometry
Exclusion
- pregnancy or breastfeeding
- any other current medication
- intake of other hawthorn preparation or dietary supplements with possible influence on the interpretation of study results
- any known diseases
- alcohol or drug abuse/addiction
- nicotine abuse
- any known hypersensitivity to any of the ingredients of the investigated drug
- inability or inadequate ability to write or speak German
- not-postmenopausal women: positive pregnancy test or unsafe contraception
- any urinary test finding requiring diagnostic assessment or treatment
- deformation of the 2nd to 5th finger of both hands preventing an adequate measurement of endothelial function
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00982501
Start Date
June 1 2008
End Date
February 1 2011
Last Update
May 14 2014
Active Locations (1)
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1
University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Salzburg, Austria, 5020