The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity (NCT01773733) | Clinical Trial Compass
CompletedNot Applicable
The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity
98,774 participantsStarted 2012-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
* Phaeochromocyt…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body Weight Loss After 3, 6 & 12 Month Treatment
Timeframe: Baseline, after 3, 6 and 12 months of treatment.