The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity (Primavera)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Promomed, LLC
ClinicalTrials.gov Identifier:
NCT01773733
First received: December 20, 2012
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

The aim of this study is to summarize the data on efficacy and safety of Reduxine administration in the routine clinical practice according to the approved indications.


Condition
Alimentary Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: All-Russia Non-interventional Program of Reduxine Safety Monitoring for Weight Reduction in Patients With Alimentary Obesity in the Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Promomed, LLC:

Primary Outcome Measures:
  • weight reduction, kg [ Time Frame: Dec 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart Rate, bpm [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]
  • Blood pressure, mmHg [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Dec 2015 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100000
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
BMI ≥ 30
BMI ≥27 kg/m2 associated with DM2

Detailed Description:

Secondary objectives:

  • to study the structure of the population of patients with the diet induced obesity with body mass index (BMI) 30 kg/m2 or diet induced obesity with BMI ≥27 kg/m2 associated with type 2 diabetes mellitus in respect of comorbidities and concomitant treatment to determine the areas for further investigations.
  • to introduce the elements of control of adverse cardiovascular risks into the routine clinical practice: questionnaire concerning enrollment criteria for Reduxine treatment initiation, algorithm of Reduxine administration and treatment efficacy and safety monitoring (assessment schedule).
  • to assess the effects of the treatment of overweight and obesity with Reduxine on patients' quality of life parameters.

The Time Frame: the follow up of the study patients will be performed during six month to one year. Exception - premature discontinuation from the study.

The scheduled visits of the patients to the investigational centres are: Week0 (inclusion of the patient), Week 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and Week 48.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men and women of 18-65 years old, in the random gender and demographical proportion, with the diagnosed overweight (BMI ≥ 27 and < 30) and obesity (BMI ≥ 30).

Criteria

Inclusion Criteria:

  • Men and women of 18-65 years of age to whom, in the doctor's opinion, the on-label use of Reduxine is indicated.
  • Patient's desire and ability to participate in the program and fulfill the doctor's instructions designed to achieve the treatment goal and the program requirements compliance.
  • Signed informed consent form for participation in the program.

Exclusion Criteria:

- Patients under age of 18 or older than 65;

Current or the history of:

  • coronary artery disease (e.g. angina, myocardial infraction);
  • congestive heart failure;
  • tachycardia;
  • peripheral arterial occlusive disease;
  • arrythmia;
  • Uncontrolled arterial hypertension >145/90 mm Hg;
  • Hypersensitivity to sibutramine or any components of Reduxine®;
  • Current use of monoamineoxidase inhibitors (IMAO) or their use within the last 2 weeks;
  • Current use of other central acting weight reducing drugs or their use within the last 2 weeks;
  • Use on other drugs affecting the central nervous system (e.g. antidepressants, neuroleptics); tryptophan-containing drugs indicated for sleep disturbance;
  • Severe eating disorder (anorexia nervosa or bulimia);
  • Mental disease;
  • Gilles de la Tourette syndrome (generalized tics);
  • Body mass index ≤30 kg/m2 or ≤27 kg/m2 in the presence of concomitant diseases (dyslipidemia, diabetes);
  • Organic cause of obesity (e.g. hypothyrosis);
  • Thyrotoxicosis;
  • Sever liver and/or kidney function abnormality;
  • Benign prostatic hyperplasia;
  • Phaeochromocytoma;
  • Narrowangle glaucoma;
  • Documented pharmacologic, drug or alcohol addiction;
  • Pregnancy and lactation;
  • Refusal to sign the informed consent form for participation in the program;
  • Participation in a clinical study of any new drug product within 90 days prior to the screening visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773733

Locations
Russian Federation
Promomed Llc
Moscow, Moscow region, Russian Federation, 299090
Sponsors and Collaborators
Promomed, LLC
  More Information

No publications provided

Responsible Party: Promomed, LLC
ClinicalTrials.gov Identifier: NCT01773733     History of Changes
Other Study ID Numbers: PROMOMED-PRIMAVERA
Study First Received: December 20, 2012
Last Updated: August 1, 2014
Health Authority: RUSSIAN FEDERATION: Ministry of Public Health

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014