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ObesityPhase 3NCT00645255

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

A Phase 3 study of Obesity and Weight Loss, run by Abbott.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study was designed to evaluate the long term efficacy and safety of Meridia 15 mg daily in obese subjects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Weight Loss
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
466 participants
Where
No sites listed yet
Study dates
Sep 1998to Jan 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

The study was designed to evaluate the long term efficacy and safety of Meridia 15 mg daily in obese subjects.

Conditions
Obesity, Weight Loss
Being tested
placebo, sibutramine or placebo
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    placebo one capsule daily

  • sibutramine or placeboDrug

    Also called ABT-911, Meridia, sibutramine

    one capsule daily

Study groups in NCT00645255
Study groupRoleWhat they receive
1OtherSingle-blind Placebo Run-in with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
Receives: Drug: placebo
2Placebo comparatorDouble-blind Treatment with behavioral intervention called Health Management Resources Maintenance Program which provided weekly classes for 12 months with meal replacement
Receives: Drug: sibutramine or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Weight Loss

    Measured: Mean Change From Baseline

Secondary outcomes (2)

  1. Body Mass Index (BMI)

    Measured: Mean Change From Baseline

  2. Waist/Hip Circumference

    Measured: Mean Change From Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2008 (estimated)
  2. Study startSep 1998
  3. Primary completionJan 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00645255
Sponsor's protocol ID
SB118
Status last verified
Mar 2008
First submitted
24 Mar 2008
Last updated
27 Mar 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Obesity and Weight Loss, run by Abbott.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight Loss (time frame: Mean Change From Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00645255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2008.

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