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About
This is Open multicenter randomized Phase IV study to evaluate the efficacy and safety of the drug Reduxin® Forte, film-coated tablets, in comparison with the drug Reduxin®, capsules, in patients with alimentary obesity was conducted in 5 cities of the Russian Federation (St. Petersburg, Ivanovo, Kirov, Samara, Rostov-on-Don) on the basis of 8 research centers.
Full description
Male and female patients (240 people) inclusive with alimentary obesity, meeting the inclusion criteria and not meeting the non-inclusion criteria, were randomized into 2 groups in a 1:1 ratio. One group (n=120) received sibutramine+ metformin p. o., 1 tablet (850 mg + 10 mg) once per day, the second group (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days.
Enrollment
Sex
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Volunteers
Inclusion criteria
Availability of the Informed Consent Form of the Patient Information Leaflet (PIL) signed and dated by patient.
Men and women aged 18 to 65 years inclusive at the time of signing the Informed Consent Form in PIL.
The presence of alimentary obesity.
BMI >30 kg/m2.
Failure of non-pharmacological treatment at the time of screening (weight loss <5% within 3 months of treatment).
Patient consent to change in diet, eating behavior, and increased physical activity, and adherence to the investigator's recommendations throughout participation in the study
Patient's consent to use reliable contraceptive methods through out the study and for 3 weeks after the end of the study. The following people could take part in the study:
Exclusion criteria
Hypersensitivity to the components of the study drug/comparator drug
Secondary (symptomatic) obesity.
Diabetes mellitus type I or II in history and/or at the time of screening.
Use of a low-calorie (<1600 kcal/day) diet for 3 months prior to screening.
Patients who previously received drugs based on sibutramine.
The use of drugs, herbal remedies or dietary supplements for the treatment of obesity less than 3 months prior to screening.
Use of systemic glucocorticosteroids for less than 3 months prior to screening.
Plan to change current smoking status during the study or quit smoking less than 3 months prior to screening.
The need for surgical treatment of obesity during the study or the history of this treatment.
Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of screening.
Impaired renal function (creatinine clearance, calculated according to the Cockcroft- Gault formula, less than 45 ml/min) at the time of screening.
Acute conditions in which there was a risk of developing impaired renal function:
dehydration (with diarrhea, vomiting), severe infectious diseases, shock (at the time of screening).
Cardiovascular diseases (in history and/or at the time of screening): ischemic heart disease (myocardial infarction, angina pectoris), chronic heart failure in the stage of decompensation, occlusive diseases of peripheral arteries, tachycardia (HR> 90 beats/min (mean for 3 measurements)), arrhythmia, cerebrovascular diseases (stroke, transient disorders of cerebral circulation).
Uncontrollable hypertension (blood pressure (BP) >145/90 mm Hg on screening).
History of pulmonary hypertension.
Clinically apparent manifestations of acute and chronic diseases that could lead to the development of tissue hypoxia (including respiratory failure, heart failure).
Hyperthyroidism.
Uncontrolled hypothyroidism at the time of screening (if using thyroid drugs or synthetic thyroid hormones, the drugs must have been used at a stable dose for at least 3 months prior to screening).
Subclinical hypothyroidism at the time of screening.
Benign prostatic hyperplasia (for men) in history.
Pheochromocytoma in history or suspicion of its presence at screening.
Angle-closure glaucoma in history.
Lactic acidosis (in history and at the time of screening).
Chronic alcoholism, acute ethanol poisoning at the time of screening.
Pharmacological and drug dependence in history and / or at the time of screening.
Serious eating disorders (anorexia nervosa, bulimia nervosa).
History of cholelithiasis or presence of symptoms of cholelithiasis within 3 months prior to screening.
History of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder or suspected of having them at the time of screening.
History of suicide attempt.
Syndrome of Gilles de la Tourette (generalized tics) in history.
Major surgery or trauma (associated with a risk to the patient's life) in the last 6 months before screening.
Planned surgery (elective surgery) at the time of screening
Uncontrolled asthma or asthma controlled by steroids.
History of seizures (with the exception of febrile seizures in childhood) or an increased risk of developing seizures.
HIV, viral hepatitis B and/or C, history of active tuberculosis.
The need for the use of drugs from the list of prohibited therapies.
Taking other medications that, in the opinion of the investigator, could affect the course and results of the clinical trial.
History of malignant neoplasms, except for patients who have not been observed for the disease within the last 5 years, patients with completely healed basal cell skin cancer or completely healed carcinoma in situ.
Severe, decompensated or unstable somatic diseases (any disease or condition that threatened the patient's life or worsened the patient's prognosis, and also made it impossible for him to participate in a clinical study).
Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of the investigator).
Pregnancy or breastfeeding period (for women).
Participation in another clinical trial within 3 months prior to study enrollment.
Other conditions that, in the opinion of the investigator, prevented the inclusion of the patient in the study.
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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