Abbott Fenofibric Acid Efficacy Study
The Tricor Metabolite
Protocol: M05-748
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Crestor (Rosuvastatin) Combination Therapy to Fenofibric Acid and Crestor (Rosuvastatin) Monotherapy in Subjects with Mixed Dyslipidemia

Tricor (FENOFIBRATE) is FDA approved & on the market. 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-7770335.115 135 mgm
Phase 3
CRO: Covance, Inc
Site #:
Investigator #:
CRA:
Central Lab:
IRB:
Subjects 1250 / 250 Sites ? 5 Subjects per Site
R in a 2:2:2:2:2:1 ratio to one of six treatment regimens as follows:
1. N-228 Fenofibric Acid 135 mgm + Two bottles Crestor Placebo
2. N-228 Fenofibric Acid 135 mgm + One bottle Crestor 10 mgm + One bottle Placebo
3. N-228 Fenofibric Acid 135 mgm + One bottle Crestor 20 mgm + One bottle Placebo
4. N-228 Crestor 10 mgm + One bottle Crestor Placebo + One bottle Fenofibric Acid Placebo
5. N-228 Crestor 20 mgm + One bottle Crestor Placebo + One bottle Fenofibric Acid Placebo
6. N-114 Crestor 40 mgm (two bottle of Crestor 20 mgm) + One bottle Fenofibric Acid Placebo
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
Equal/greater than 18
Mixed Dyslipidemia (Fredrickson Type IIb)
Fast equal/greater than 12H with: TG ?150; HDL <40 Men or < 50 Women; LDL ?130
EC
MI, CVA PTCA, CABG within 12 months; Stage III CHF or EF ? 40; Use of any experimental drug within 42 days V3 Baseline
Asian Ancestry; Coumadin; abnormal TSH, IDDM, HgbA1C > 8.5, LFT > 1.5, < 8 wks stable ERT or Synthroid; CC < 50 ml/min.

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

Abbott Fenofibric Acid Efficacy Study
The Tricor Metabolite
Protocol: M05-748

V1 W -6 Day -42 Pre-screening Lab D/C all Cholesterol Meds, IVRS . Unique screening # assigned, ICF
V2 W -1 Day -7 Screening, Lab, IVRS, Dry Ice
V2.1 Optional second screening visit if a lab is within 30% cut . . off value, Lab, Dry Ice
V3 W 0 Day 1 Baseline, assign subject # & study drug kit # via IVRS, . . . Diary, Take 1st dose study drug in office today; EKG; Lab
Dry Ice
V4 W 4 Day 29 Interim Visit +/- 3D, Lab, IVRS, Diary . . call IVRS for study drug kit assignment
V5 W 8 Day 57 Interim Visit +/- 3D, Lab, IVRS, Diary . . call IVRS for study drug kit assignment
V6 W 12 Day 85 Final/Discontinuation Visit, IVRS, early term. Lab . Join open-label safety extension study, Dry Ice
V7 W 16 Day 115 Safety F/U 30 Days after V6 for subjects who elect not to . join the open-label extension phase MO5-758
At visits V2 – V6 compliance with the AHA dietary instructions: “An Eating Plan for healthy Americans” will be assessed and documented as follows:
1. Compliant: Subject adheres to AHA diet at least 75% of the time
2. Partially Compliant: Subject adheres to AHA diet at least 25 to 75% of the time
3. Non-Compliant: Subject adheres to AHA diet less than 25% of the time
Investigator meeting Orlando The Rosen Centre Hotel 18-20 January 2006 Susan & PI