19 April 2005
VERSION: 1 2 3 4 5 6 7 8 9

DiZo Study
Diovan/Zocor
DiZo Study
Diovan/Zocor
19 April 2005
VERSION: 1 2 3 4 5 6 7 8 9

V1 D -42 to -29 Washout Period 1 ICF, TLC, D/C Lipid & BP Meds
Assign unique patient number, window +/- 3 days, RTC 14 D
V2 D -28 to -15 SB Run-in Period 2 Lab, UA, EKG, TLC, SBP ? 135 and < 180, CPE, +/- 3 days, RTC 14-28 D
V3 D -14 to -1 Lab, TLC, SBP ? 145 and < 180 & LDL > 100, window +/- 3 days, RTC 1 - 14 D
V4a D 0 Apply ABPM (Ambulatory Blood Pressure Monitoring) (urine pregnancy test)
V4 D 1 Remove ABPM, Double Blind Treatment Period 3 R
Lab, SBP ? 140 and < 180, TLC, Assign Randomization Number, window +/- 3 days
Remind subjects they will have blood drawn for Pharmacogenetic Biomarkers this visit
V5 D 15 Lab TLC window +/- 3 days, RTC 14 Days
V6 D 29 Lab TLC window +/- 3 days, RTC 13 Days
V7a D 42 Apply ABPM (Ambulatory Blood Pressure Monitoring)
V7 D 43 Lab, Remove ABPM TLC window +/- 3 days
DiZo Study
Diovan/Zocor
19 April 2005
VERSION: 1 2 3 4 5 6 7 8 9

Moderate to High Doses of Statins
defined as at least:
1. Mevacor (Lovastatin)....40
2. Zocor (Simvastatin).....20
3. Pravachol (Pravastatin).80
4. Lescol (Fluvastatin)....80
5. Lipitor (Atorvastatin)..20
6. Crestor (Rosuvastatin)..10