Evaluation of Long Term Safety of Tesofensine in Patients With Obesity

This study has been completed.
Sponsor:
Information provided by:
NeuroSearch A/S
ClinicalTrials.gov Identifier:
NCT00481104
First received: May 31, 2007
Last updated: July 1, 2011
Last verified: March 2008
  Purpose

Purpose of the study is to evaluate the long term safety of tesofensine in obese patients


Condition Intervention Phase
Obesity
Drug: Tesofensine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Long Term Safety of Tesofensine in Patients With Obesity

Resource links provided by NLM:


Further study details as provided by NeuroSearch A/S:

Primary Outcome Measures:
  • Safety measures: Treatment emergent adverse events, vital signs (BP and HR), ophthalmoscopy, ECG, laboratory assessments and physical examination

Secondary Outcome Measures:
  • Effect measures: Body weight, waist circumference, waist-hip ratio, BMI, Metabolic measures

Enrollment: 140
Study Start Date: May 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who have completed their participation in TIPO-1

  • Males and females 18 to 65,5 years of age, extremes included
  • Patients continuously receiving diet therapy as well as instructions on exercise
  • Females of childbearing potential must be non-pregnant and use safe contraceptive methods (the pill, IUD, injection of prolonged gestagen, sub dermal implantation, hormonal vaginal devices, transdermal patches or surgically sterilized)
  • Patients should be able to comply with study procedures
  • Patients giving written informed consent

Exclusion Criteria:

  • Patients with a BMI< 22
  • Use of prescription medication as listed in Appendix 1
  • Positive pregnancy test for women of childbearing potential
  • Pregnant women, or women who are planning to become pregnant within the next 8 months
  • Patients with specific diseases interfering with their metabolism e.g. untreated myxoedema, Cushing's syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia.
  • Patients 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
  • Patients known to abuse or to be dependent on any drug, including alcohol (weekly consumption > 21 units of alcohol (men) or >14 units of alcohol (women))
  • 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)
  • Known untreated hypercholesterolaemia (> 7 mmol/l). Patients with well regulated cholesterol using drugs for hypercholesterolaemia are allowed inclusion
  • Known untreated hypertriglyceridaemia (> 3 mmol/l). Patients with well regulated triglyceride levels using drugs for hypertriglyceridaemia are allowed inclusion
  • Drug treated thyroid diseases (well substituted hypothyroidism is allowed)
  • Patients who suffer from hyperthyroid disease are not allowed in the study, even though they may be well treated by drugs
  • Patients, who have recently diagnosed, not yet stable hypothyroid disease are not allowed in the study
  • Patients who suffer from longstanding stable hypothyroid disease, well treated substitution are allowed to be included including hypothyroidism as a sequelae to definitive treatment of hyperthyroidism by surgery or radioactive iodine
  • Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine
  • Special diets (e.g., vegetarian, Atkins)
  • Patients planning major changes in physical activity during the study to an extent that may interfere with the study outcome, as judged by the investigator
  • Mental or psychiatric disorder based on medical history only
  • Surgically treated obesity
  • Patients with systemic infections or inflammatory diseases
  • 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 > 480 milliseconds (ms) in females and >450 ms in males, 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
  • Uncontrolled hypertension (i.e. sitting diastolic BP ≥ 95 mm Hg and sitting systolic BP ≥ 155 mm Hg) despite treatment for > 4 weeks prior to the screening visit as well as HR>90 bpm
  • Known HIV infection (no tests required)
  • History of cancer within the past 5 years, excluding treated basal cell carcinoma
  • Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma
  • Current treatment with medication with known ocular toxicity such as chloroquine and hydroxychloroquine is prohibited
  • Patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481104

Locations
Denmark
Faculty of Life Sciences, University of Copenhagen
Copenhagen, Frederiksberg, Denmark, 1958
Sponsors and Collaborators
NeuroSearch A/S
Investigators
Principal Investigator: Arne V Astrup, Professor, MD Faculty of Life Science, University of Copenhagen, Denmark
  More Information

No publications provided by NeuroSearch A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00481104     History of Changes
Other Study ID Numbers: NS2330-004
Study First Received: May 31, 2007
Last Updated: July 1, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by NeuroSearch A/S:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014