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Effect of Tesofensine on Energy Balance in Humans.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00428415
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : March 5, 2008
Sponsor:
Information provided by:
NeuroSearch A/S

Tracking Information
First Submitted Date  ICMJE January 29, 2007
First Posted Date  ICMJE January 30, 2007
Last Update Posted Date March 5, 2008
Study Start Date  ICMJE March 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2007)
Effect on 24-h EE (energy expenditure) after 14 days dosing, adjusted for FFM(Fat-Free Mass) and FM (Fat Mass) changes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2007)
  • 24-h fat oxidation, spontaneous physical activity, fecal excretion of energy and fat (respiratory chamber),Changes in body weight and composition
  • Physical Measure(Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA, Spontaneous energy intake at lunch test
  • Metabolic measures (Total triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin, Adiponectin, FFA, CCK, Ghrelin, and Leptin)
  • Data from questionnaires( Satiety & Appetite, POMS Brief)
  • Safety & Tolerability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Tesofensine on Energy Balance in Humans.
Official Title  ICMJE The Effect of Tesofensine on Energy Balance in Humans. A Randomised, Double-Blind, Placebo-Controlled, Parallel- Group, Single Centre Study.
Brief Summary

Purpose:

To evaluate the effect of tesofensine on energy balance

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Drug: Tesofensine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 29, 2007)
32
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overweight to obese subjects with BMI 28 - 35 kg/m² otherwise healthy
  • Males 18 to 50 years of age, extremes included
  • Subjects should be able to comply with study procedures
  • Subjects giving written informed consent

Exclusion Criteria:

  • Use of any concomitant medication including high dose vitamins and regular OTC preparations
  • Subjects who have been smokers within the last year
  • Subjects with specific diseases interfering with their metabolism e.g. myxoedema, Cushing's syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia.
  • Subjects with Type 2 diabetes mellitus are ineligible unless anti-diabetic medication was not deemed necessary by the investigator and fasting (venous or arterialized capillary full blood from finger or ear) blood glucose > 6.1 mmol/l at screening. Re-test is allowed if first measure is above inclusion value. The corresponding exclusion criteria for plasma glucose is 7.0 mmol/l
  • Known hypercholesterolaemia (> 7 mmol/l).
  • Known hypertriglyceridaemia (> 3 mmol/l).
  • Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine
  • Mental or psychiatric disorder based on medical history only
  • Subjects with systemic infections or inflammatory diseases
  • Subjects currently (within the past 2 months) known to abuse or to be dependent on any drug, including alcohol (weekly consumption > 21 units of alcohol )
  • Hepatic or renal dysfunction (ASAT and/or ALAT > 2 x ULN and creatinine clearance < 30 mL/min estimated by central laboratory using Cockcroft and Gault formula, respectively)
  • Special diets (e.g., vegetarian, Atkins)
  • Subject should not be athletics or planning major changes in physical activity during the study to an extent that may interfere with the study outcome, as judged by the investigator
  • Weight change of > 3 kg within 2 months prior to screening
  • Surgically treated obesity
  • History or presence of significant cardiovascular disease such as heart failure, ischemic heart disease, stroke, transient ischemic attacks
  • Significant abnormalities on the ECG according to the investigators opinion. Additional exclusionary ECG values: QTcB > 450 milliseconds(ms), PR interval > 240 ms, QRS interval > 120 ms
  • Hypotension (i.e. supine systolic BP < 90 mm Hg) and/or symptomatic orthostatic hypotension (clinical symptoms of orthostatic hypotension associated with a decline ≥ 20 mm Hg in systolic BP at one minute after standing compared with the previous supine systolic BP obtained after 5 minutes of quiet rest) at screening visit
  • Hypertension (i.e. sitting diastolic BP ≥ 95 mm Hg and sitting systolic BP ≥ 155 mm Hg) as well as HR>90 bpm
  • Known HIV infection (no tests required)
  • Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma
  • Serologic evidence of active hepatitis B and/or C
  • History of cancer within the past 5 years, excluding treated basal cell carcinoma
  • Subjects previously treated with tesofensine
  • Subjects treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00428415
Other Study ID Numbers  ICMJE TIPO-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE NeuroSearch A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arne V Astrup, MD Department of Human Nutrition, The Royal Veterinary & Agricultural University
PRS Account NeuroSearch A/S
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP