Abbott FA (Fenofibric Acid) Safety Extension Trial
The Tricor Metabolite
Protocol M05-758: FA 135 + Crestor 20
A Long-Term, Open-Label, Safety Extension Study of the Combination of FA (Fenofibric Acid) and Crestor Statin Therapy for Subjects with Mixed Dyslipidemia

Tricor (FENOFIBRATE) is FDA approved & on the market. FA (Fenofibric Acid) is not FDA approved, however. Tricor (Fenofibrate) is rapidly converted to Fenofibric acid during absorption. Fenofibric acid, not Tricor (Fenofibrate), is found circulating in plasma.
Sponsor: Abbott Laboratories
Study Drug: Fenofibric Acid Choline Salt, ABT-335, A-7770335.115 FA 135 mgm
Phase 3
CRO: Covance, Inc
Site #:
Investigator #:
CRA:
Central Lab:
IRB:
Subjects 1250 / 250 Sites: 5 Subjects per Site
IVRS (Integrated Voice Response System) by ICTI (Interactive Clinical Technologies, Inc.)
Rates for Rhabdomyolysis with Tricor plus a statin: 0.58 case per million prescriptions.
IC
Susscessfully completed protcol MO5-748
EC
Has not successfully completed protocol MO5-748
Diet Compliance Assessment (Low; Medium; or, High)
Low: Follows diet < 25 % of the time
Medium: Follows Diet between 25-75 % of the time
High: Follows Diet > 75% of the time
Investigator meeting was in Orlando at The Rosen Centre Hotel 18-20 January 2006 attended by Susan & PI

22 January 2006
VERSION: 1 2 3 4 5 6 7 8 9

Abbott FA (Fenofibric Acid) Safety Extension Trial
The Tricor Metabolite
Protocol M05-758: FA 135 + Crestor 20

V1 W 0 Day -1 Same as V6 core trial; Baseline, Lab, New ICF, . First Dose Open Label Drugs taken the following day, . . Diet Compliance Assessment (Low; Medium; or, High)
V2 W 4 Day 28 Lab +/- 3 D, Dietary Compliance Assessment
V3 W 8 Day 56 Lab +/- 3 D, Dietary Compliance Assessment
V4 W 12 Day 84 Lab +/- 3 D, Dietary Compliance Assessment
V5 W 16 Day 112 Lab +/- 3 D, Dietary Compliance Assessment
V6 W 28 Day 196 Lab +/- 7 D, Dietary Compliance Assessment
V7 W 40 Day 280 Lab +/- 7 D, Dietary Compliance Assessment
V8 W 52 Day 364 Lab; Final /Discontinuation Visit +/- 7 D, Diet, EKG
V9 W 56 Day 394 30 Day or less Safety F/U Contact to assess AE’s