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

PHASE4CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

July 3, 2020

Primary Completion Date

May 21, 2021

Study Completion Date

May 21, 2021

Conditions
Obesity
Interventions
DRUG

metformin+sibutramine

1 tablet (850 mg + 10 mg) once per day in the morning, without chewing and followed with a glass of water, during meals, for 180 days. At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit1 (Day 1), the zero dose was increased to 1 tablet (850 mg + 15 mg)

DRUG

sibutramine+ microcrystalline cellulose

1 capsule (10 mg + 158.5 mg) once per day in the morning, without chewing and followed with a glass of water, during meals for, 180 days.At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit 1 (Day 1), the zero dose was increased to 1 capsule (15 mg + 153,5 mg)

Trial Locations (8)

Unknown

Ivanovo Clinical Hospital named after Kuvaev, Ivanovo

Kirov State Medical University, Kirov

Pirogov Russian National Research Medical University, Moscow

"Rostov State Medical University of the Ministry of Health of the Russian Federation", Rostov-on-Don

"Clinical hospital RZD-Medicine of the city of St. Petersburg", Saint Petersburg

Avrora Limited Liability Company Principal, Saint Petersburg

"Limited Liability Company Medica", Saint Petersburg

OrKli Hospital Limited Liability Company, Saint Petersburg

All Listed Sponsors
lead

Promomed, LLC

OTHER

NCT05821543 - Efficacy and Safety of Sibutramin-containing Drugs in Patient With Alimentary Obesity | Biotech Hunter | Biotech Hunter