Conditions: Obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 493
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (2 tablets 3 times daily) for 24 weeks. arm 2: Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (1 tablet 6 times daily) for 24 weeks. arm 3: Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (2 tablets 3 times daily) for 24 weeks. arm 4: Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (1 tablet 6 times daily) for 24 weeks.

Interventions: intervention 1: Dietressa intervention 2: Placebo
Intervention descriptions: intervention 1: Comparison of different dosages (frequency) of drug intervention 2: Placebo either (2 tablets 3 times daily) or

(1 tablet 6 times daily)

Protocol document: