evaluation of long term safety of tesofensine in patients with obesity

Conditions: Obesity

Summary: purpose of the study is to evaluate the long term safety of tesofensine in obese patients


Eligibility 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

Keywords: obesity