None listed
Conditions
Interventions
Group 1 Type of group
Placebo for 111 weeks
Group name:Group 5 Type of group
Taranabant 6 mg for one year and then taranabant 2 mg for 2 years
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient has a body mass index (BMI) (see Appendix 1) between 30 kg / m2 and 43 kg / m2 inclusive (BMI between 27 kg / m2 and .43 kg / m2 inclusive for those with comorbidities related to obesity) and has maintained a stable weight (± 3 kg) for at least 3 months before the start of the study. • The patient meets at least 1 of the following 4 criteria in Visit 1 (Week-3): 1) Triglyceride levels> 150 mg / dL (1.69 mmol / L) but 130 mm Hg or diastolic blood pressure in sitting position> 85 mm Hg 4) Fasting glucose intolerance (FPG> 100 mg / dL [5.5 mmol / L] and 18 years of age. • It is very unlikely that the patient conceives as indicated, at least, with an affirmative answer to the following questions: 1) The patient is a man. 2) The patient is a surgically sterilized woman (bilateral tubal ligation, hysterectomy or bilateral oophorectomy). 3) The patient is a postmenopausal woman. Postmenopausal status is defined as> 43 years of age and (1) absence of menstruation for> 1 year but <3 years and confirmed by elevated FSH levels to the postmenopausal range (as defined by the designated Clinical Laboratory) or (2) ) absence of menstruation for at least 3 years. 4) The patient is a non-sterilized premenopausal woman who is not heterosexually active (and does not plan to become heterosexually active during the course of the study), or is willing to use 2 appropriate barrier contraceptive methods to prevent pregnancy throughout the study beginning at Visit 1 (Week -3) and up to 28 days after the last dose of the study drug. • The patient understands the study procedures and agrees to participate in the study by giving written informed consent. • The patient is able to read, understand and complete the study questionnaires.
Exclusion criteria
Exclusion criteria: • The patient has a history or presence of a major DSM-IV-TR psychiatric disorder, including, without a limiting sense, substance-related disorders, schizophrenia and other psychotic disorders, mood disorders (eg, major depression, bipolar disorder) or eating disorders (for example, bulimia, anorexia nervosa). • The patient has a history of seizures or is at high risk of developing seizures (for example: patients with a history of brain tumors, severe head trauma, or intracranial hemorrhage). • The patient has inadequately controlled hypertension (JNC 7 Stage 2: systolic blood pressure> 160 mm Hg or diastolic blood pressure> 100 mm Hg). • The patient has diabetes mellitus, as defined in their medical history, or fasting blood glucose> 126 mg / dL (7.0 mmol / L) or random blood glucose> 200 mg / dL (11.1 mmol / L) or use oral or injectable antihyperglycemic drugs. • The patient has any endocrinopathy or the patient has an abnormal TSH level in the selection (as defined by the normal range of the Central Laboratory). Exception: Patients with adequately treated thyroid dysfunction can be enrolled (with stable drug delivered by at least 6 weeks before randomization). • The patient has a marked hypertriglyceridemia (triglycerides in fasting> 600 mg / dL n [6.8 mmol / L]). • The patient currently has significant cardiovascular disease, including, without a limiting sense: unstable angina or valvular heart disease or has had myocardial infarction, coronary artery bypass graft with graft or percutaneous transluminal coronary angioplasty, congestive heart failure or arrhythmias within 6 last months. • The patient has an active liver disease or a history of chronic liver disease (eg, viral hepatitis, nonalcoholic steatohepatitis confirmed with a biopsy). • The patient has a history of significant lung disease. • The patient has a history or presence of a significant gastrointestinal disease, including, without a limiting sense, cholelithiasis. • The patient has a history of significant kidney disease. • The patient is HIV positive, as determined by his medical history. • The patient has a history of neoplastic disease. • The patient has undergone surgical treatment for obesity. Exception: The procedure to which the patient was subjected occurred at least 5 years before the selection and there is no clinical evidence of complications, including, without a limiting sense, malabsorption. • The patient has undergone a surgical procedure within 4 weeks prior to Visit I (Week -3), or plans to undergo a surgical procedure during the study. Exception: Patients with a history of minor surgery (for example, with local anesthesia) within 4 weeks prior to selection and who are fully recovered may participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Comparing the mean change with respect to the baseline in body weight between the groups treated with placebo, and doses of 2 mg and 4 mg of taranabant Measure:Body weight variation after 52 weeks Timepoints:52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Comparing the mean change with respect to the baseline in body weight between the groups treated with placebo, and doses of 2 mg and 4 mg of taranabant Measure:Proportion of obese patients who lose> 5% or> 10% of their baseline body weight in Week 52 Timepoints:Week 52 ; Outcome name:comparing the doses of 2 mg and 4 mg of taranabant with placebo, using a logistic model with terms for treatment, change in weight during the transition period, region and an indicator for each of the 5 components of metabolic syndrome at baseline . Measure:Proportion of patients who have metabolic syndrome in Week 52 Timepoints:Week 52 ; Outcome name:through clinical and / or statistical review of all safety parameters, including adverse events, laboratory values and signs, vital. Measure:Safety and Tolerability Timepoints:During the study | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed