Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459745
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2007-04-09
Brief Title:
A Study to Evaluate Daily Pravastatin Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia
Sponsor:
Shionogi
Organization:
Shionogi Inc
Study Overview
Official Title:
A Multi-Center Prospective Longitudinal Randomized Double-Blind Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen the Combination of Pravastatin and Fenofibrate 40160 mg for 12 Weeks Followed by a 52-Week Open-Label Safety Phase of the Pravafen Alone in the Treatment of Combined Hyperlipidemia
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center double blind prospective longitudinal randomized 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen the combination of both Pravastatin and Fenofibrate 40160 mg in the treatment of combined hyperlipidemia There will be an open-label 8-week Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mgday Following the Selection Phase and if the patients meet all inclusionexclusion criteria they will be randomized to a three arm double blind 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen the combination of Pravastatin and Fenofibrate 40160 mg The 12-week Efficacy Phase will be followed by an open-label 52-week Safety Phase in which all patients will receive Pravafen
After the 8-week Selection Phase patients that still meet the inclusionexclusion criteria will be randomized on a 112 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen the combination of both Pravastatin and Fenofibrate 40160 mg for 12 weeks After the completion of the 12-week double-blind phase of the study all patients that havent had changes in their well being will be allowed to roll-over into the 52-week open-label follow-up portion of the study During the 52 week open label Safety Phase of the study all patients will receive Pravafen the combination of Pravastatin and Fenofibrate 40160 mg
Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study Patients that roll-over into the 52-week open-label follow-up Safety Phase will be evaluated at 12 24 36 and 52 weeks
Participation in the study can be up to 72 weeks
After the 8-week Selection Phase patients that still meet the inclusionexclusion criteria will be randomized on a 112 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen the combination of both Pravastatin and Fenofibrate 40160 mg for 12 weeks After the completion of the 12-week double-blind phase of the study all patients that havent had changes in their well being will be allowed to roll-over into the 52-week open-label follow-up portion of the study During the 52 week open label Safety Phase of the study all patients will receive Pravafen the combination of Pravastatin and Fenofibrate 40160 mg
Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study Patients that roll-over into the 52-week open-label follow-up Safety Phase will be evaluated at 12 24 36 and 52 weeks
Participation in the study can be up to 72 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None