NCT00134160

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

Completed Phase 4 Last updated 3 October 2010

What this trial tests

Phase 4 trial testing Olmesartan medoxomil in Hypertension in 1,000 participants. Completed in 1 May 2010.

Timeline

1 August 2005

Primary endpoint
1 May 2010

1 May 2010

Quick facts

Lead sponsor	OSCAR Study
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,000
Start date	1 August 2005
Primary completion	1 May 2010
Estimated completion	1 May 2010
Sites	2 locations across Japan

Drugs / interventions tested

• Olmesartan medoxomil (OLMESARTAN MEDOXOMIL) — full drug profile →
• Calcium channel blockers (amlodipine, azelnidipine) — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

OSCAR Study

Who can join

Adults 65 to 84, any sex, with Hypertension or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack)
  Time frame: 36 Months
• Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia)
  Time frame: 36 Months
• Heart failure
  Time frame: 36 Months
• Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases)
  Time frame: 36 Months
• Diabetic complications (nephropathy, retinopathy and neuropathy)
  Time frame: 36 Months
• Renal dysfunction (doubling of serum creatinine, end stage renal diseases)
  Time frame: 36 Months

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Blood pressure control for diabetic retinopathy.
   Do DV, Wang X, Vedula SS, Marrone M, et al · · 2015 · cited 94× · PMID 25637717 · DOI 10.1002/14651858.cd006127.pub2
2. An angiotensin II receptor blocker-calcium channel blocker combination prevents cardiovascular events in elderly high-risk hypertensive patients with chronic kidney disease better than high-dose angiotensin II receptor blockade alone.
   Kim-Mitsuyama S, Ogawa H, Matsui K, Jinnouchi T, et al · · 2013 · cited 32× · PMID 23051740 · DOI 10.1038/ki.2012.326
3. Rationale, design and patient baseline characteristics of OlmeSartan and calcium antagonists randomized (OSCAR) study: a study comparing the incidence of cardiovascular events between high-dose angiotensin II receptor blocker (ARB) monotherapy and combination therapy of ARB with
   Ogawa H, Kim-Mitsuyama S, Jinnouchi T, Matsui K, et al · · 2009 · cited 14× · PMID 19444280 · DOI 10.1038/hr.2009.60