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
1 other identifier
interventional
60
1 country
1
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 versus nordic walking training in overweight subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 22, 2009
CompletedFirst Posted
Study publicly available on registry
September 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMay 14, 2014
May 1, 2014
2.3 years
September 22, 2009
May 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Adverse events
12 weeks
Lab parameters
12 weeks
Vital signs
12 weeks
Treadmill test including lactate measurement
12 weeks
Secondary Outcomes (1)
Endothelial function
12 weeks
Study Arms (4)
WS® 1442 900 mg
EXPERIMENTALWS® 1442 1800 mg
EXPERIMENTALNordic walking training 2x30 min
ACTIVE COMPARATORNordic walking training 4x45 min
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Salzburg, 5020, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josef Niebauer, M.D., Ph.D.
University Institute of Sports Medicine, Prevention and Rehabilitation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 22, 2009
First Posted
September 23, 2009
Study Start
June 1, 2008
Primary Completion
September 1, 2010
Study Completion
February 1, 2011
Last Updated
May 14, 2014
Record last verified: 2014-05