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Evaluation of Long Term Safety of Tesofensine in Patients With Obesity
Plain-language guide to NCT00481104: phase 2 interventional trial of Tesofensine (non-peptide), 140 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00481104
- Phase
- phase 2
- Status
- completed
- Start
- 2007-05
- Completion (planned or actual)
- 2008-09
- Participants
- 140 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Tesofensine (non-peptide).
Purpose of the study is to evaluate the long term safety of tesofensine in obese patients.
The registry classes the interventions as drug.
Who Took Part
The registry lists 140 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Males and females 18 to 65,5 years of age, extremes included. Patients continuously receiving diet therapy as well as instructions on exercise. Patients should be able to comply with study procedures. Patients giving written informed consent.
The full record lists 5 inclusion and 29 exclusion criteria; among the exclusions: patients with a bmi\< 22; use of prescription medication as listed in appendix 1; positive pregnancy test for women of childbearing potential.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Tesofensine (non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2007-05 with completion listed for 2008-09.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Safety measures: Treatment emergent adverse events, vital signs (BP and HR), ophthalmoscopy, ECG, laboratory assessments and physical examination.
It also tracked 1 secondary outcome, for example Effect measures: Body weight, waist circumference, waist-hip ratio, BMI, Metabolic measures.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Tesofensine (non-peptide) in 140 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tesofensine (non-peptide) compound page, all human trials.
Our Notes on the Compound
Tesofensine (non-peptide): An oral triple reuptake inhibitor (serotonin, norepinephrine, dopamine).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.