NCT01535014

Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients

Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 493 (actual)
• Sponsor: Materia Medica Holding · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is: * To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients. * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients. * To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.

Detailed description

In general, patients will be observed during 24 weeks of trial.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Dietressa	Comparison of different dosages (frequency) of drug
DRUG	Placebo	Placebo either (2 tablets 3 times daily) or (1 tablet 6 times daily)

Timeline

• Start date: 2011-12-12
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-02-17
• Last updated: 2018-11-28
• Results posted: 2018-10-18

Locations

17 sites across 1 country: Russia