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Sibutramine

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321. Acute effect of weight loss on levels of total bilirubin in obese, cardiovascular high-risk patients: an analysis from the lead-in period of the Sibutramine Cardiovascular Outcome trial. (Abstract)

Acute effect of weight loss on levels of total bilirubin in obese, cardiovascular high-risk patients: an analysis from the lead-in period of the Sibutramine Cardiovascular Outcome trial. Low levels of bilirubin are associated with an increased risk of cardiovascular adverse events. Weight reduction is known to reduce several cardiovascular risk factors, but effects on bilirubin levels have not been reported. We studied the response of weight loss therapy with sibutramine and lifestyle change (...) on levels of total bilirubin in an overweight or obese, cardiovascular high-risk population. Data from the first 4 weeks of the lead-in period of the Sibutramine Cardiovascular Outcome study were analyzed. A total of 10 198 patients provided body weight measurements before and after 4 weeks of sibutramine treatment (10 mg daily), of whom 1059 (10.4%) gained weight, 1467 (13.7%) lost greater than 0% to 1%, 2492 (23.2%) lost greater than 1% to 2%, 2280 (21.2%) lost greater than 2% to 3%, 1498 (13.9%) lost

2009 Metabolism: clinical and experimental Controlled trial quality: uncertain

322. Tesofensine--a novel potent weight loss medicine. Evaluation of: Astrup A, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo- Full Text available with Trip Pro

with tesofensine in obese subjects.After 26 weeks, tesofensine caused a significant weight loss, and may have a higher maximal ability to reduce weight than the presently available anti-obesity agents. However, tesofensine also increased blood pressure and heart rate, and may increase psychiatric disorders.It is encouraging that tesofensine 0.5 mg may cause almost double the weight loss observed with sibutramine or rimonabant. As tesofensine and sibutramine have similar pharmacological profiles, it would (...) be of interest to compare the weight loss with tesofensine in a head-to-head clinical trial with sibutramine, to properly assess their comparative potency. Also, as teso fensine 0.5 mg increases heart rate, as well as increasing the incidence of adverse effects such as nausea, drug mouth, flatulence, insomnia, and depressed mode, its tolerability needs to be further evaluated in large Phase III clinical trials.

2009 Expert opinion on investigational drugs

323. Potent and selective agonism of the melanocortin receptor 4 with MK-0493 does not induce weight loss in obese human subjects: energy intake predicts lack of weight loss efficacy. (Abstract)

ratio (GMR) with 95% confidence interval (CI) for total energy intake over a period of 24 h for 30 mg sibutramine/placebo was 0.82 (0.76, 0.88), and for 10 mg sibutramine/placebo it was 0.98 (0.91, 1.05). MK-0493 showed a small and marginally significant effect on 24-h energy intake, whereas 30 mg of sibutramine caused a significant reduction in total 24-h energy intake; specifically, the GMR (95% CI) for 30 mg sibutramine/placebo was 0.79 (0.74, 0.85). MK-0493 was associated with modest weight

2009 Clinical pharmacology and therapeutics Controlled trial quality: uncertain

324. Predictors of attrition and weight loss success: Results from a randomized controlled trial. Full Text available with Trip Pro

Predictors of attrition and weight loss success: Results from a randomized controlled trial. Attrition is a common problem in weight loss trials. The present analysis examined several baseline and early-treatment process variables, as predictors of attrition and outcome in a clinical trial that combined pharmacotherapy and behavior therapy for weight loss. Participants were 224 obese adults who were treated with sibutramine alone, lifestyle modification alone, combined therapy, or sibutramine

2009 Behaviour research and therapy Controlled trial quality: uncertain

325. Comparative bioavailability of two formulations of sibutramine. (Abstract)

Comparative bioavailability of two formulations of sibutramine. This study was conducted in order to compare the bioavailability of two capsule formulations containing 15 mg of sibutramine, N-{1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutyl}-N,N-dimethylamine hydrochloride monohydrate, 84485-00-7 CAS registry number. 62 healthy subjects were enrolled in a single-center, randomized, single-dose, open-label, 2-way crossover study, with a minimum washout period of 14 days. Plasma samples were (...) collected up to 72.0 hours post-dosing. R-sibutramine, S-sibutramine, N-mono-desmethyl-sibutramine (M1) and N-di-desmethyl-sibutramine (M2) levels were determined by reverse liquid chromatography and detected by tandem mass spectrometry detection, LC/MS/MS method. Pharmacokinetic parameters used for bioequivalence assessment were the area under the concentration-time curve from time zero to time of last non-zero concentration (AUC0-t) and the maximum observed concentration (Cmax). These parameters were

2009 International journal of clinical pharmacology and therapeutics Controlled trial quality: uncertain

326. Study of Treatment for Adolescents With Bulimia Nervosa

on drugs or alcohol; current diagnosis of anorexia nervosa or weight less that 85% IBW; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; currently taking medication for co-morbid conditions for less than 2-months; currently taking medications that may induce weight loss, e.g., appetite suppressants such as sibutramine, phentermine, and xenical, unless the participant is willing to withdraw from such medications; currently taking medications for symptoms of BN

2009 Clinical Trials

327. A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

Thyroid replacement therapy Antidepressant agents Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over the counter antiobesity agents Exclusion Criteria: Has ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog Has received any investigational drug within one month (or five half-lives

2009 Clinical Trials

328. Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia

Cholestin red yeast rice fish oils plant sterols and stanols orlistat sibutramine isotretinoin tacrolimus Probucol Systemic corticosteroids and androgens Potent CYP3A4 inhibitors Cyclosporine Erythromycin Clarithromycin Telithromycin human immunodeficiency virus protease inhibitors amiodarone diltiazem verapamil nefazodone grapefruit juice Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff

2009 Clinical Trials

329. A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus

of the patient or for the purposes of the study Exclusion Criteria: Use of an excluded medication/therapy including any of the following: Steroids Oral hypoglycemic agents Chemotherapy and radiation Immunosupressants Nicotinamide >100 mg per day Any drugs containing sibutramine Female patients with a positive pregnancy test or who are lactating Adult patients with body weight <45 kg; adolescent patients with body weight <30 kg; 10- and 11-year-old patients with body weight <25 kg History of cancer or have

2009 Clinical Trials

330. The Effects of Exenatide After Gastric Restriction

), Have experienced hypersensitivity reaction or a worsening of glycemic control on Byetta® (exenatide), Patients with end stage renal disease or severe renal impairment, Patients with severe gastrointestinal disease, including gastroparesis, Liver function tests 2.5 standard deviations above normal values, Contraindication for bariatric surgery, Treatment with exenatide (Byetta) in the last three months, Currently using or have used within three months before this trial: sibutramine, orlistat

2009 Clinical Trials

331. Safety of Lapaquistat Acetate in Subjects With Hypercholesterolemia

serious disease or condition at Visit 1 that may reduce life expectancy, impair successful management according to the protocol, or make the participant unsuitable to receive study medication. Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: Orlistat Sibutramine Isotretinoin Tacrolimus Probucol Systemic corticosteroids

2009 Clinical Trials

332. Effect of South Beach Diet (SBDâ„¢) Using SBDâ„¢ Products Compared to the American Diabetic Association (ADA) Diabetes Meal Plan on Body Weight and Satiety in Diabetic Women

or over the counter products known to effect weight including but not limited to the following: megestrol acetate; somatropin; sibutramine; orlistat; paroxetine; dextroamphetamine; methylphenidate; atomoxetine; quetiapine; olanzepine; risperidone, within 4 weeks of randomization and during the trial Unstable medication for diabetes mellitus (Dosage must be stable for 90 days prior to randomization), use of insulin is exclusionary Alcohol use > 2 standard alcoholic drinks per day Significant cardiac

2009 Clinical Trials

333. Gastric Bypass and Peripheral Activity of the Endocannabinoid System

and humans. Obese patients, especially those with abdominal obesity, have significantly higher levels of endocannabinoids. No influence of moderate (5%) body weight loss (induced either by diet intervention or sibutramine) on the peripheral activity of the endocannabinoid system gastric bypass (GB) surgery is the most efficient treatment of obesity Hormonal pathways may participate to the weight reducing effect of the procedure.The endocannabinoid system is present in the gastrointestinal tract

2009 Clinical Trials

334. Vitamin D Supplementation in Psychiatric Illnesses

, and sibutramine, Subjects on medications that might affect glucose levels, such as insulin or metformin. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004354 Locations Layout table for location information United States, Massachusetts University

2009 Clinical Trials

335. The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

to treat obesity including medications obtained over the counter or internet, orlistat (Xenical, Alli), sibutramine (Meridia), topiramate (with or without phentermine (Qsymia), phentermine (Adipex P) or lorcaserin (Belviq) within the past 6 months History of an eating disorder including anorexia or bulimia History of surgery for the treatment of obesity (gastric banding, gastric bypass) Diagnosis of type 1 or type 2 diabetes mellitus according to American Diabetes Association guidelines Previous

2009 Clinical Trials

336. Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

medications (e.g. sibutramine, orlistat, rimonabant), History of pancreatitis. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851903 Locations Layout table for location information United States, New Jersey Sanofi-Aventis Administrative Office

2009 Clinical Trials

337. Evaluation of the Remote Intervention for Diet and Exercise (RIDE)

medications such as sibutramine, antipsychotic medications such as olanzapine, ephedrine, and diuretics). Diagnosed with uncontrolled hypertension (high blood pressure), defined as systolic blood pressure >159 mmHg & diastolic blood pressure >99 mmHg. For females, current pregnancy, or plans to become pregnant in the duration of the study. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff

2009 Clinical Trials

338. A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin. Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening. Are currently treated with any of the following excluded medications: Thiazolidinediones (TZD) within 3 months of screening. Sulfonylurea (SU) within 3 months of screening. Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3

2009 Clinical Trials

339. Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one (...) or more studies before adding more. Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00941382 Recruitment Status : Unknown Verified July 2009 by Laboratorios Silanes S.A. de C.V.. Recruitment status

2009 Clinical Trials

340. 5-HT(1A) Activation Counteracts Cardiovascular But Not Hypophagic Effects of Sibutramine in Rats. Full Text available with Trip Pro

5-HT(1A) Activation Counteracts Cardiovascular But Not Hypophagic Effects of Sibutramine in Rats. The noradrenaline (NA) and serotonin reuptake inhibitor, sibutramine, gives effective weight loss, but full efficacy cannot be attained at approved doses due to cardiovascular side effects. We assessed in rats the contributions of NA and serotonin transporters to sibutramine's hypophagic and cardiovascular effects, and whether selective 5-hydroxytryptamine (5-HT(1A)) receptor activation could (...) counteract the latter without affecting the former. Food intake was assessed in freely feeding rats and cardiovascular parameters in conscious telemetered rats. Ex vivo radioligand binding was used to estimate brain monoamine transporter occupancy. Sibutramine (1-10 mg/kg p.o.) dose-dependently reduced food intake; however, 10 mg/kg p.o. markedly elevated blood pressure and heart rate. Sibutramine gave greater occupancy of NA than serotonin reuptake sites. Coadministration of the selective 5-HT(1A

2009 Obesity

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