Safety and Efficacy of Low Doses of V24343 in Obese Subjects
Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo to study the effect of V24343 on blood pressure and weight in obese subjects.
The primary variables, change in blood pressure (BP) and pulse, will be assessed both by outpatient ambulatory monitoring of vital signs and by regular clinic monitoring.
The efficacy of V24343 will be assessed by measurement of body weight, waist circumference, bioimpedance assessment of body composition and blood glucose.
Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing will be used to assess the pharmacokinetics of V24343.
Other safety assessments comprise routine monitoring of adverse events; concomitant medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and self-completed psychiatric assessments.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||A Double-blind, Placebo-controlled, Parallel Group Study of the Effect of V24343 on Blood Pressure and Weight in Obese Subjects|
- To examine any effects of V24343 on pulse and blood pressure (vital signs) [ Time Frame: 24-hour on screening and pre-dose on Days 2, 26 and 56. Semi -recumbent and stand SBP , DBP and pulse, in duplicate at each time point. ] [ Designated as safety issue: Yes ]
- To determine if there is adequate differentiation between doses of V24343 associated with any effect on vital signs and those associated with efficacy (weight loss). [ Time Frame: Body weight and wasit circumference: screen and time-matched to pre-dose on Days -1, 8, 15, 22, 29, 35, 42, 49 and 56. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Randomised to a parallel group comparison of either one of four doses of study drug (1mg, 2mg, 5mg, 25mg) or placebo. Dosed once daily for 28 days
Oral, 1mg, 2 mg, 5 mg or 25 mg, or placebo, once daily for 28 days