NCT01570829

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Materia Medica Holding · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Dietressa	Oral administration.
DRUG	Placebo	Oral administration.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-04-04
• Last updated: 2021-08-26
• Results posted: 2021-08-26

Locations

17 sites across 1 country: Russia