Trial Outcomes & Findings for The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity (NCT NCT01773733)
NCT ID: NCT01773733
Last Updated: 2024-01-19
Results Overview
Patients were weighed at each visit, but the statistical data processing was carried out after 3, 6 and 12 months of treatment.
Recruitment status
COMPLETED
Target enrollment
98774 participants
Primary outcome timeframe
Baseline, after 3, 6 and 12 months of treatment.
Results posted on
2024-01-19
Participant Flow
98774 patients signed ICF (Informed Consent Forms), but only 93313 patients started Reduxine treatment, as soon as 5461 patients discontinued prior to the treatment start due to contraindications detected after ICF completion.
Participant milestones
| Measure |
Patients With Obesity
Patients 18-65 y.o. with obesity (BMI≥ 30 kg/m2)
|
Patients With Overweight Associated With DM2
Patients 18-65 y.o. with DM2 and owerweigt (BMI ≥ 27 kg/m2)
|
|---|---|---|
|
Overall Study
STARTED
|
80146
|
13167
|
|
Overall Study
3 Months of Treatment
|
54841
|
11365
|
|
Overall Study
6 Months of Treatment
|
33424
|
8007
|
|
Overall Study
COMPLETED
|
21417
|
4846
|
|
Overall Study
NOT COMPLETED
|
58729
|
8321
|
Reasons for withdrawal
| Measure |
Patients With Obesity
Patients 18-65 y.o. with obesity (BMI≥ 30 kg/m2)
|
Patients With Overweight Associated With DM2
Patients 18-65 y.o. with DM2 and owerweigt (BMI ≥ 27 kg/m2)
|
|---|---|---|
|
Overall Study
Adverse Event
|
3286
|
540
|
|
Overall Study
Pregnancy
|
28
|
0
|
|
Overall Study
Other different categories of not compl
|
55415
|
7781
|
Baseline Characteristics
Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
Baseline characteristics by cohort
| Measure |
Patients With Obesity
n=80146 Participants
Patients 18-65 y.o. with obesity (BMI≥ 30 kg/m2)
|
Patients With Overweight Associated With DM2
n=13167 Participants
Patients 18-65 y.o. with DM2 and overweight (BMI ≥ 27 kg/m2)
|
Total
n=93313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=80146 Participants
|
0 Participants
n=13167 Participants
|
0 Participants
n=93313 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80146 Participants
n=80146 Participants
|
13167 Participants
n=13167 Participants
|
93313 Participants
n=93313 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=80146 Participants
|
0 Participants
n=13167 Participants
|
0 Participants
n=93313 Participants
|
|
Sex: Female, Male
Female
|
46617 Participants
n=56643 Participants • Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
|
10836 Participants
n=13167 Participants • Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
|
57453 Participants
n=69810 Participants • Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
|
|
Sex: Female, Male
Male
|
10026 Participants
n=56643 Participants • Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
|
2331 Participants
n=13167 Participants • Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
|
12357 Participants
n=69810 Participants • Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
|
PRIMARY outcome
Timeframe: Baseline, after 3, 6 and 12 months of treatment.Population: Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
Patients were weighed at each visit, but the statistical data processing was carried out after 3, 6 and 12 months of treatment.
Outcome measures
| Measure |
Obesity
n=56643 Participants
Patients 18-65 y.o. with alimentary obesity BMI (Body Mass Index) ≥ 30 kg/m2
|
Overweight & Risk Factors
n=13167 Participants
Patients 18-65 y.o. overweight, BMI ≥ 27 kg/m2 plus T2DM (type 2 diabetes mellitus) or dyslipidemia
|
|---|---|---|
|
Body Weight Loss After 3, 6 & 12 Month Treatment
Body weight loss after 6 month treatment
|
-15.0 kg
Standard Error 6.2
|
-14.4 kg
Standard Error 5.9
|
|
Body Weight Loss After 3, 6 & 12 Month Treatment
Body weight loss after 3 month treatment
|
-9.5 kg
Standard Error 4.3
|
-9.0 kg
Standard Error 4.19
|
|
Body Weight Loss After 3, 6 & 12 Month Treatment
Body weight loss after 12 month treatment
|
-20.0 kg
Standard Error 8.6
|
-19.2 kg
Standard Error 8.25
|
SECONDARY outcome
Timeframe: From the 1st day of Reduxine treatment until the end of the treatmentPopulation: Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
Percentage of participants with all adverse events since the start of the Reduxine treatment to the end of the study
Outcome measures
| Measure |
Obesity
n=56643 Participants
Patients 18-65 y.o. with alimentary obesity BMI (Body Mass Index) ≥ 30 kg/m2
|
Overweight & Risk Factors
n=13167 Participants
Patients 18-65 y.o. overweight, BMI ≥ 27 kg/m2 plus T2DM (type 2 diabetes mellitus) or dyslipidemia
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
4.1 percentage of participants
|
4.1 percentage of participants
|
Adverse Events
Obese
Serious events: 0 serious events
Other events: 2322 other events
Deaths: 0 deaths
Overweight & Risk Factors
Serious events: 0 serious events
Other events: 540 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Obese
n=56643 participants at risk
Patients 18-65 y.o.with alimentary obesity, BMI (Body Mass Index) ≥ 30 kg/m2)
|
Overweight & Risk Factors
n=13167 participants at risk
Patients 18-65 y.o., overweight, BMI ≥ 27 kg/m 2 plus T2DM ( type 2 diabetes mellitus) or dyslipidemia
|
|---|---|---|
|
Nervous system disorders
Dry mouth
|
1.6%
906/56643 • Number of events 906 • 1 year
|
1.6%
210/13167 • Number of events 210 • 1 year
|
|
General disorders
Headache
|
0.90%
511/56643 • Number of events 511 • 1 year
|
0.90%
119/13167 • Number of events 119 • 1 year
|
|
Nervous system disorders
Insomnia
|
0.80%
453/56643 • Number of events 453 • 1 year
|
0.80%
105/13167 • Number of events 105 • 1 year
|
|
Cardiac disorders
Hypertension/increased blood pressure
|
0.30%
170/56643 • Number of events 170 • 1 year
|
0.30%
39/13167 • Number of events 39 • 1 year
|
|
Cardiac disorders
tachycardia
|
0.20%
114/56643 • Number of events 114 • 1 year
|
0.20%
26/13167 • Number of events 26 • 1 year
|
|
Nervous system disorders
Depression
|
0.30%
170/56643 • Number of events 170 • 1 year
|
0.30%
39/13167 • Number of events 39 • 1 year
|
|
General disorders
Other Adverse Events
|
1.2%
673/56643 • Number of events 673 • 1 year
|
1.2%
157/13167 • Number of events 157 • 1 year
|
Additional Information
Prof. Ivan I . Dedov, Director of the Endocrinology Research Centre
FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
Phone: +7 499 124 4300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place