Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134160
Status:
COMPLETED
Last Update Posted:
2010-10-05
First Post:
2005-08-22
Brief Title:
OlmeSartan and Calcium Antagonists Randomized OSCAR Study
Sponsor:
OSCAR Study
Organization:
OSCAR Study
Study Overview
Official Title:
The Study Comparing the Incidence of Cardiovascular Events Between High-dose ARB Monotherapy and Combination Therapy With ARB and Calcium Channel Blocker in Japanese Elderly Hypertensive Patients at High Cardiovascular Risk
Status:
COMPLETED
Status Verified Date:
2010-10
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:
The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker ARB monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone
Detailed Description:
Hypertension is one of the major risk factors of cardiovascular diseases It is also important for elderly hypertensive patients to strictly reduce their blood pressures to prevent cardiovascular events Although angiotensin II receptor blockers ARBs are increasingly used in antihypertensive treatment recently few studies have been performed in Japan to assess the difference between high-dose ARB monotherapy and combination therapy of ARB with calcium channel blocker CCB in prevention of cardiovascular diseases for patients whose blood pressure is not well controlled by ARB monotherapy OSCAR-study is a multicenter active-controlled 2-arm parallel group comparison prospective randomized open blinded end-point PROBE design study The dose administered is olmesartan medoxomil 20mgday as ARB monotherapy in the Step 1 period If the blood pressure is not adequately controlled and treatment is well tolerated then the dose is changed to olmesartan medoxomil 40mgday in the high-dose ARB monotherapy group or olmesartan medoxomil 20mgday and a CCB in the combination therapy group in the Step 2 period At least 500 patients will be enrolled in each group and the follow-up duration will be 3 years The primary objective is to compare the incidence of a composite of fatal and non-fatal cardiovascular events and all cause mortality between the two treatment groups
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