Study to Examine the Longer-Term Efficacy and Safety of Sibutramine Hydrochloride in Obese Subjects
Primary Purpose
Obesity, Weight Loss
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
placebo
sibutramine or placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- The subject must be able to communicate meaningfully with the investigator, be legally competent, provide written informed consent, and follow a specified diet and exercise program.
- Female subjects must be nonlactating and must either be a) at least one year postmenopausal; or b) surgically sterilized by bilateral tubal ligation, bilateral oophorectomy or hysterectomy; or c) using adequate contraceptive precautions (i.e., oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide).
- A serum pregnancy test, which must be negative, is required of all females except those who are surgically sterile or postmenopausal.
- The subject must be at least 18 years old.
- The subject must have a systolic blood pressure <=140 mmHg, a diastolic blood pressure<=90 mmHg, and a pulse rate <=95 beats per minute (see Section VI.I.). Treated hypertensives are allowed in the study.
- The subject must have been enrolled in a nonpharmacologic weight loss program with documented weight loss of >=10 kg maintained for at least 6 months, have gained back <50% of their peak lost weight (while currently maintaining a weight loss of >=10 kg), and be stabilized on a weight-maintaining diet for at least 1 month prior to screening.
- The subject's body mass index (BMI) must be >=27 kg/m2 and <=40 kg/mg2, rounded to the nearest whole unit, and must have been >=30 kg/m2 prior to initiation of the nonpharmacological weight loss program prior to screening.
- The subject must have lived in the immediate geographic area for at least 2 years prior to screening.
- If the subject is on chronic medication, the dose must have been constant for at least two months prior to screening.
Exclusion Criteria:
- The subject must not have a history of anorexia nervosa.
- The subject must not have a history of clinically significant cardiac disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.
- The subject must not have a history of stroke.
- The subject must not have a history of narrow angle glaucoma.
- The subject must not have an organic cause of obesity (e.g., untreated hypothyroidism).
- The subject must not have a history of seizures.
- The subject must not have severe renal or hepatic dysfunction.
- The subject must not be using any of the following medications while taking study medication: monoamine oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine HCl, selegiline), lithium, serotonin reuptake inhibitors, opioids (e.g., dextromethorphan, meperidine, pentazocine, fentanyl), prescribed or over-the-counter weight loss agents, centrally acting appetite suppressants, tryptophan, migraine agents (e.g., sumatriptan succinate, dihydroergotamine) or any other medication that, in the opinion of the Investigator, may pose harm to the subject, obscure the effects of study medication or interfere with the process of drug absorption, distribution, metabolism, or excretion (i.e., enzyme inducers or enzyme inhibitors). The regular use of sympathomimetics (e.g. cough and cold remedies, asthma medication) is contraindicated during the study. Study medication should be discontinued for 3 days before the use of opioids. THE SUBJECT SHOULD NOT BE TAKEN OFF ANTIDEPRESSANTS IN ORDER TO BE PLACED IN THE STUDY.
- The subject must not have a history of hypersensitivity to MERIDIA.
- The subject must not have a history of alcohol or drug addiction.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
1
2
Arm Description
Single-blind Placebo Run-in with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
Double-blind Treatment with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
Outcomes
Primary Outcome Measures
Body Weight Loss
Secondary Outcome Measures
Body Mass Index (BMI)
Waist/Hip Circumference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00645255
Brief Title
Study to Examine the Longer-Term Efficacy and Safety of Sibutramine Hydrochloride in Obese Subjects
Official Title
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Examine the Longer-Term Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Study Start Date
September 1998 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study was designed to evaluate the long term efficacy and safety of Meridia 15 mg daily in obese subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
466 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Single-blind Placebo Run-in with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Double-blind Treatment with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo one capsule daily
Intervention Type
Drug
Intervention Name(s)
sibutramine or placebo
Other Intervention Name(s)
ABT-911, Meridia, sibutramine
Intervention Description
one capsule daily
Primary Outcome Measure Information:
Title
Body Weight Loss
Time Frame
Mean Change From Baseline
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Time Frame
Mean Change From Baseline
Title
Waist/Hip Circumference
Time Frame
Mean Change From Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject must be able to communicate meaningfully with the investigator, be legally competent, provide written informed consent, and follow a specified diet and exercise program.
Female subjects must be nonlactating and must either be a) at least one year postmenopausal; or b) surgically sterilized by bilateral tubal ligation, bilateral oophorectomy or hysterectomy; or c) using adequate contraceptive precautions (i.e., oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide).
A serum pregnancy test, which must be negative, is required of all females except those who are surgically sterile or postmenopausal.
The subject must be at least 18 years old.
The subject must have a systolic blood pressure <=140 mmHg, a diastolic blood pressure<=90 mmHg, and a pulse rate <=95 beats per minute (see Section VI.I.). Treated hypertensives are allowed in the study.
The subject must have been enrolled in a nonpharmacologic weight loss program with documented weight loss of >=10 kg maintained for at least 6 months, have gained back <50% of their peak lost weight (while currently maintaining a weight loss of >=10 kg), and be stabilized on a weight-maintaining diet for at least 1 month prior to screening.
The subject's body mass index (BMI) must be >=27 kg/m2 and <=40 kg/mg2, rounded to the nearest whole unit, and must have been >=30 kg/m2 prior to initiation of the nonpharmacological weight loss program prior to screening.
The subject must have lived in the immediate geographic area for at least 2 years prior to screening.
If the subject is on chronic medication, the dose must have been constant for at least two months prior to screening.
Exclusion Criteria:
The subject must not have a history of anorexia nervosa.
The subject must not have a history of clinically significant cardiac disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.
The subject must not have a history of stroke.
The subject must not have a history of narrow angle glaucoma.
The subject must not have an organic cause of obesity (e.g., untreated hypothyroidism).
The subject must not have a history of seizures.
The subject must not have severe renal or hepatic dysfunction.
The subject must not be using any of the following medications while taking study medication: monoamine oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine HCl, selegiline), lithium, serotonin reuptake inhibitors, opioids (e.g., dextromethorphan, meperidine, pentazocine, fentanyl), prescribed or over-the-counter weight loss agents, centrally acting appetite suppressants, tryptophan, migraine agents (e.g., sumatriptan succinate, dihydroergotamine) or any other medication that, in the opinion of the Investigator, may pose harm to the subject, obscure the effects of study medication or interfere with the process of drug absorption, distribution, metabolism, or excretion (i.e., enzyme inducers or enzyme inhibitors). The regular use of sympathomimetics (e.g. cough and cold remedies, asthma medication) is contraindicated during the study. Study medication should be discontinued for 3 days before the use of opioids. THE SUBJECT SHOULD NOT BE TAKEN OFF ANTIDEPRESSANTS IN ORDER TO BE PLACED IN THE STUDY.
The subject must not have a history of hypersensitivity to MERIDIA.
The subject must not have a history of alcohol or drug addiction.
12. IPD Sharing Statement
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Study to Examine the Longer-Term Efficacy and Safety of Sibutramine Hydrochloride in Obese Subjects
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