Orexigen Begins Fourth Phase III Trial
Orexigen™ Therapeutics, Inc. announced on December 11, the start of the fourth of four trials in its Phase III clinical trial program for Contrave™, one of it's two promising weight loss drugs.
This clinical trial is a 56-week study designed to assess the safety, tolerability and efficacy of Contrave™ in otherwise healthy, nondiabetic, obese patients. At the 28 week mark, anyone who hasn't responded to the Contrave™ will be re-randomized and either continue with the same dosage or receive a higher dose for the remaining 28 weeks. The trial is designed to take place at approximately 50 centers nationwide and will include about 1500 patients.
The first Phase III clinical trial for Contrave™ started enrolling subjects in April and is scheduled to run for 56 weeks and will test weight loss potential either alone or combined with intense diet, exercise and behavior modification. It is currently taking place in nine centers across the country and enrollment has been completed.
The second Phase III trial started enrolling subjects in May. It's also scheduled to run 56 weeks and will be testing obese subjects with Type II diabetes. It's taking place in approximately 50 locations and the expected enrollment is 525 patients.
In October the third Phase III trial began enrolling patients who are non-diabetic, healthy and obese. The plan is to use 60 centers around the country and enroll about 1650 patients for the 58 week test.
For more information, please visit http://ir.orexigen.com/releasedetail.cfm?ReleaseID=280910
Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion
This clinical trial is a 56-week study designed to assess the safety, tolerability and efficacy of Contrave™ in otherwise healthy, nondiabetic, obese patients. At the 28 week mark, anyone who hasn't responded to the Contrave™ will be re-randomized and either continue with the same dosage or receive a higher dose for the remaining 28 weeks. The trial is designed to take place at approximately 50 centers nationwide and will include about 1500 patients.
The first Phase III clinical trial for Contrave™ started enrolling subjects in April and is scheduled to run for 56 weeks and will test weight loss potential either alone or combined with intense diet, exercise and behavior modification. It is currently taking place in nine centers across the country and enrollment has been completed.
The second Phase III trial started enrolling subjects in May. It's also scheduled to run 56 weeks and will be testing obese subjects with Type II diabetes. It's taking place in approximately 50 locations and the expected enrollment is 525 patients.
In October the third Phase III trial began enrolling patients who are non-diabetic, healthy and obese. The plan is to use 60 centers around the country and enroll about 1650 patients for the 58 week test.
For more information, please visit http://ir.orexigen.com/releasedetail.cfm?ReleaseID=280910
Technorati Tags: Contrave™ naltrexone Diet Pills Weight Loss Pillsbupropion
posted by Ken MacKenzie @ 7:04 PM
0 comments
