A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan (Benicar) Based Treatment Regimen in Elderly Patients with Stage I and Stage II Hypertension
Sponsor: Daiichi Sankyo, Inc
Study Drug: Benicar = Olmesartan
Protocol: 866-450
CRO: Integrium
CRA:
SAE Hotline ->
Project Manager:
Site #:
Central Lab:
Last day to enroll subjects:
Central IRB:
200 Subjects/ 25 Sites = 8 pts per site
BP Criteria: SBP equal/greater than 150 AND equal/less than 199 DBP equal/less than 109 (At V3 + V4 or V4 + Vx)
V4a mean daytime (8AM – 4PM) SBP equal/greater than 140 AND equal/less than 199
V4a mean daytime (8AM – 4PM) DBP equal/less than 109
IC
Age equal/greater than 65
BP equal/greater than 140/90
EC
Non-dominant arm < 24 cm or > 42 cm
Cardiovascular event within 6 months; AF
IDDM; NIDDM with FBS > 160
Night Shift Workers
Dig; Coumadin
Effexor or Lithium
Narcotics
Albuterol or Serevent
Viagra
Dexatrim, Meridia or Phentermine
21 September 2006
VERSION: 1 2 3 4 5 6 7 8 9
Benicar
Angiotensin II Antagonist
Vs Lab, ICF, Screen, EKG
V1 W-3 D -21 Placebo Run-In
V2 W-2 D -14
V3 W-1 D -7 BP Criteria
V4 W-1 D -1 BP Criteria
V4x W-1 D -1 ABPM Hookup, BP Criteria Optional V
V4a W0 D 0 ABPM Removal and Download, Begin Benicar 20 if:
Mean daytime SBP by ABPM is equal/greater than 140 AND equal/less than 199
Mean daytime DBP is equal/less than 109
V5 W3 D21 Uptitrate Benicar 40 if equal/greater than 140/90, ET if equal/greater than 180/110
V6 W6 D42 Uptitrate Benicar-HCT 40-12.5 if equal/greater than 140/90, ET if equal/greater than 180/110
V7 W9 D63 Uptitrate Benicar-HCT 40-25 if equal/greater than 140/90, ET if equal/greater than 180/110
V8 W12 D84 ABPM Hookup, ET if equal/greater than 180/110
V8a W12 D85 ABPM Removal and Download