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Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
This study has been completed.
Study NCT00518466   Information provided by VIVUS, Inc.
First Received: August 16, 2007   Last Updated: March 9, 2009   History of Changes

August 16, 2007
March 9, 2009
July 2007
September 2007   (final data collection date for primary outcome measure)
Pharmacokinetic parameters [ Time Frame: One month ]
Same as current
Complete list of historical versions of study NCT00518466 on ClinicalTrials.gov Archive Site
 
 
 
Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
A Phase Ib, Open Label, Parallel-Design Single- and Multiple-Dose Study Comparing Modified Release Topiramate Formulations to Immediate Release Formulations of Topiramate Dosed in Combination With Immediate Release Phentermine in Obese Adults

The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.

 
Phase I
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Obesity
  • Drug: topiramate
  • Drug: phentermine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
64
December 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese adults
  • Body mass index between 30.0 and 42.0 kg/m2 (inclusive)
  • Medically healthy with no clinically significant results of screening exams

Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
  • History of glaucoma or increased intraocular pressure
  • History of kidney stones
  • Cholelithiasis or cholecystitis within 6 months
  • Cardiovascular event within 6 months
  • Obesity of known genetic or endocrine origin
  • Recent weight instability
  • Use of Very Low Calorie diet or participation in organized weight loss program within 3 months
  • Systolic blood pressure > 150 or diastolic > 95 mm Hg
  • Positive urine drug or alcohol screen
  • Positive serology for HIV, HBV, or HCV
  • History of alcoholism or drug abuse
  • History of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation
  • Hypersensitivity to study drug or related compounds
  • Use of prescription or OTC medication other than hormonal contraceptive within 14 days prior to first dosing with study drug
  • Blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug
  • Women who are pregnant or lactating
  • Hemoglobin < 12 g/dL
  • Use of tobacco or nicotine-containing products within 6 months
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00518466
Wesley Day, VP Clinical, Vivus, Inc.
OB-102 / AA42851
VIVUS, Inc.
 
Study Director: Wesley W Day, PhD VIVUS, Inc.
VIVUS, Inc.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP