OverweightPhase 1NCT00982501
WS®1442 in Slightly Overweight Subjects
A Phase 1 study testing WS® 1442 900 mg/d, WS® 1442 1800 mg/d and Nordic walking training 2 x 30 min/week in people with Overweight, run by Dr. Willmar Schwabe GmbH & Co. KG at 1 site in Austria.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- WS® 1442 900 mg/d, WS® 1442 1800 mg/d and Nordic walking training 2 x 30 min/week
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2008to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Salzburg, 5020
About this study
Official title: Investigation of Safety of WS®1442 in Slightly Overweight Subjects With Pilot Assessment of Pharmacodynamic Effects of WS®1442 on Endothelial Function
The purpose of this study is to test:
- Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²)
- Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects
Read the 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
- Being tested
- WS® 1442 900 mg/d, WS® 1442 1800 mg/d, Nordic walking training 2 x 30 min/week, Nordic walking training 4x45 min/week
- Keywords
- (BMI 25-29,9 kg/m2)
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WS® 1442 900 mg/dDrug
WS® 1442 1800 mg/dDrug
Nordic walking training 2 x 30 min/weekBehavioural
Nordic walking training 4x45 min/weekBehavioural
| Study group | Role | What they receive |
|---|---|---|
| WS® 1442 900 mg | Experimental | Not described Receives: Drug: WS® 1442 900 mg/d |
| WS® 1442 1800 mg | Experimental | Not described Receives: Drug: WS® 1442 1800 mg/d |
| Nordic walking training 2x30 min | Active comparator | Not described Receives: Behavioral: Nordic walking training 2 x 30 min/week |
| Nordic walking training 4x45 min | Active comparator | Not described Receives: Behavioral: Nordic walking training 4x45 min/week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 12 weeks
Lab parameters
Measured: 12 weeks
Vital signs
Measured: 12 weeks
Treadmill test including lactate measurement
Measured: 12 weeks
Secondary outcomes (1)
Endothelial function
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Josef Niebauer, M.D., Ph.D., Principal investigator, University Institute of Sports Medicine, Prevention and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982501
- Sponsor's protocol ID
- 501004.01.103
- Status last verified
- May 2014
- First submitted
- 22 Sep 2009
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety of WS®1442 in Slightly Overweight Subjects With Pilot Assessment of Pharmacodynamic Effects of WS®1442 on Endothelial Function
- ClinicalTrials.gov ID
- NCT00982501
- Acronym / sponsor ID
- 501004.01.103
- Conditions
- Overweight
- Keywords
- (BMI 25-29,9 kg/m2)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Willmar Schwabe GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test:
- Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²)
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WS® 1442 900 mg | Experimental | Drug: WS® 1442 900 mg/d |
| WS® 1442 1800 mg | Experimental | Drug: WS® 1442 1800 mg/d |
| Nordic walking training 2x30 min | Active comparator | Behavioral: Nordic walking training 2 x 30 min/week |
| Nordic walking training 4x45 min | Active comparator | Behavioral: Nordic walking training 4x45 min/week |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WS® 1442 900 mg/d | Drug | WS® 1442 900 mg |
| WS® 1442 1800 mg/d | Drug | WS® 1442 1800 mg |
| Nordic walking training 2 x 30 min/week | Behavioural | Nordic walking training 2x30 min |
| Nordic walking training 4x45 min/week | Behavioural | Nordic walking training 4x45 min |
Primary outcome
Adverse events
Time frame: 12 weeks
Lab parameters
Time frame: 12 weeks
Vital signs
Time frame: 12 weeks
Treadmill test including lactate measurement
Time frame: 12 weeks
1 secondary outcome
Endothelial function
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Niebauer, M.D., Ph.D. principal investigator
University Institute of Sports Medicine, Prevention and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WS® 1442 900 mg/d, WS® 1442 1800 mg/d and Nordic walking training 2 x 30 min/week in people with Overweight, run by Dr. Willmar Schwabe GmbH & Co. KG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.