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