Evaluation of Long Term Safety of Tesofensine in Patients With Obesity

July 1, 2011 updated by: NeuroSearch A/S
Purpose of the study is to evaluate the long term safety of tesofensine in obese patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark, 1958
        • Faculty of Life Sciences, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Effect measures: Body weight, waist circumference, waist-hip ratio, BMI, Metabolic measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroSearch A/S

Investigators

  • Principal Investigator: Arne V Astrup, Professor, MD, Faculty of Life Science, University of Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

May 31, 2007

First Posted (Estimate)

June 1, 2007

Study Record Updates

Last Update Posted (Estimate)

July 4, 2011

Last Update Submitted That Met QC Criteria

July 1, 2011

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NS2330-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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