Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients

Summary

* To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients (BMI 35,0-39,9 kg/m2). * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily after 24 weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).

Timeline

Start

2011-12

Primary completion

2013-06

Completion

2013-06

Outcome

Met primary endpoint

registry analysis (superiority test); Dietressa vs Placebo; p = 0.0352; Fisher Exact NCT01570829 ↗

registry analysis (superiority test); Dietressa vs Placebo; p = 0.0001; Wilcoxon (Mann-Whitney) NCT01570829 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dietressa	Unknown	—	Oral

Indications