Evaluation of Long Term Safety of Tesofensine in Patients With Obesity

Obesity Clinical Trial

Official title:

Evaluation of Long Term Safety of Tesofensine in Patients With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481104
• Other study ID #: NS2330-004
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2007
• Last updated: July 1, 2011
• Start date: May 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2008
• Source: NeuroSearch A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Tesofensine

Locations

Country	Name	City	State
Denmark	Faculty of Life Sciences, University of Copenhagen	Copenhagen	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
NeuroSearch A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measures: Treatment emergent adverse events, vital signs (BP and HR), ophthalmoscopy, ECG, laboratory assessments and physical examination
Secondary	Effect measures: Body weight, waist circumference, waist-hip ratio, BMI, Metabolic measures