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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
1 tablet (850 mg + 10 mg) once per day in the morning, without chewing and followed with a glass of water, during meals, for 180 days. At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit1 (Day 1), the zero dose was increased to 1 tablet (850 mg + 15 mg)
1 capsule (10 mg + 158.5 mg) once per day in the morning, without chewing and followed with a glass of water, during meals for, 180 days.At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit 1 (Day 1), the zero dose was increased to 1 capsule (15 mg + 153,5 mg)
Ivanovo Clinical Hospital named after Kuvaev
Ivanovo, Russia
Kirov State Medical University
Kirov, Russia
Pirogov Russian National Research Medical University
Moscow, Russia
"Rostov State Medical University" of the Ministry of Health of the Russian Federation
The rate of achieving >5% weight loss
The proportion of patients who had achieved more than 5% weight loss
Time frame: From baseline to Visit 13 (study completion, 180 days)
The frequency of patients who required an increase in the dose of the study / reference drug
The proportion of the patients requiring an increase in the study / reference dose
Time frame: From baseline to Visit 3 (30±1 days)
The magnitude of the change in body weight
Value of weight change calculated as weight on Visit 13 to baseline (kg)
Time frame: From baseline to Visit 13 (study completion, 180 days)
The change in Body Mass Index (BMI)
The average value of the change in BMI (%)
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of body weight
The mean body weight by each two weeks (kg)
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of BMI
The average value of BMI by every month (kg/m2)
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of waist measurement
The average waist measurement by every month(cm)
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of hip width
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rostov-on-Don, Russia
"Clinical hospital "RZD-Medicine" of the city of St. Petersburg"
Saint Petersburg, Russia
Avrora Limited Liability Company Principal
Saint Petersburg, Russia
Limited Liability Company "Medica"
Saint Petersburg, Russia
OrKli Hospital Limited Liability Company
Saint Petersburg, Russia
The average hip width by every month(cm)
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of waist / hip measurements
The average value of the ratio waist / hip measurements by every month
Time frame: From baseline to Visit 13 (study completion, 180 days)
Dynamics of lipid profile indicators (TG, total cholesterol, LDL-cholesterol, HDL-cholesterol)
The mean value of triglyceride, total cholesterol, LDL- cholesterol, HDL - cholesterol (mmol/l) by every month
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of quality of life
The data obtained using the SF-36 Quality of life questionnaire, the average score of the physical health and psychological health by every month
Time frame: From baseline to Visit 13 (study completion, 180 days)