Study to Examine the Longer-Term Efficacy and Safety of Sibutramine Hydrochloride in Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645255
Recruitment Status : Terminated
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
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Brief Summary:
The study was designed to evaluate the long term efficacy and safety of Meridia 15 mg daily in obese subjects.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Drug: placebo Drug: sibutramine or placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 1998
Actual Primary Completion Date : January 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Single-blind Placebo Run-in with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
Drug: placebo
placebo one capsule daily

Placebo Comparator: 2
Double-blind Treatment with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
Drug: sibutramine or placebo
one capsule daily
Other Names:
  • ABT-911
  • Meridia
  • sibutramine

Primary Outcome Measures :
  1. Body Weight Loss [ Time Frame: Mean Change From Baseline ]

Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: Mean Change From Baseline ]
  2. Waist/Hip Circumference [ Time Frame: Mean Change From Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Peter Bacher, MD, PhD, Abbott Identifier: NCT00645255     History of Changes
Other Study ID Numbers: SB118
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents