drugset / Trial / NCT05821543

Efficacy and Safety of Sibutramin-containing Drugs in Patient With Alimentary Obesity

NCT05821543

Phase 4 Completed 240 enrolled Promomed, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-07-03
Primary completion
2021-05-21
Completion
2021-05-21

Publications

  • Background Demidova T.Yu., Izmailova M.Y., Ushakova S.E., Zaslavskaya K.Y., Odegova A.A., Popova V.V., Nevretdinova M.E., Bely P.A. EVALUATION OF WEIGHT REDUCTION EFFICACY AND SAFETY OF SIBUTRAMIN-CONTAINING DRUGS IN PATIENTS WITH ALIMENTARY OBESITY. Pharmacy & Pharmacology. 2022;10(3):289-304. https://doi.org/10.19163/2307-9266-2022-10-3-289-304

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 850 mg Oral
Background Sibutramine Small molecule 15 mg

Indications