NCT00134160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 5, 2010

Status Verified

October 1, 2010

Enrollment Period

4.8 years

First QC Date

August 22, 2005

Last Update Submit

October 3, 2010

Conditions

HypertensionCardiovascular Diseases

Keywords

AgedHypertensionCardiovascular DiseasesAngiotensin II Type 1 Receptor BlockersCalcium Channel BlockersCombination Drug TherapyDiabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (7)

  • 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)

    36 Months

  • Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia)

    36 Months

  • Heart failure

    36 Months

  • Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases)

    36 Months

  • Diabetic complications (nephropathy, retinopathy and neuropathy)

    36 Months

  • Renal dysfunction (doubling of serum creatinine, end stage renal diseases)

    36 Months

  • All cause mortality

    36 Months

Secondary Outcomes (3)

  • Development of each cardiovascular event

    36 Months

  • Blood pressure change (systolic blood pressure [SBP], diastolic blood pressure [DBP], mean blood pressure [MBP]) at every observation point in the follow-up period

    36 Months

  • Serious adverse events other than primary outcome events

    36 Months

Study Arms (2)

1

ACTIVE COMPARATOR

High-dose ARB monotherapy

Drug: Olmesartan medoxomil

2

ACTIVE COMPARATOR

Combination therapy of ARB with Calcium Channel Blocker

Drug: Calcium channel blockers (amlodipine, azelnidipine)

Interventions

Olmesartan medoxomilDRUG

Olmesartan medoxomil 40mg/Day

1
Calcium channel blockers (amlodipine, azelnidipine)DRUG

Olmesartan medoxomil 20mg/Day with Calcium channel blockers (amlodipine or azelnidipine)

2

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex
  • Current antihypertensive treatment with monotherapy
  • SBP ≥ 140mmHg or DBP ≥ 90mmHg in a sitting position on two measurements on two clinic visits
  • At least one of the following risk factors:
  • Diabetes mellitus Type 2;
  • History of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (more than 6 months before giving informed consent);
  • Diagnosis of asymptomatic cerebrovascular disease;
  • History of myocardial infarction (more than 6 months before giving informed consent);
  • Diagnosis of angina pectoris or heart failure (New York Heart Association \[NYHA\] functional classification I or II);
  • Diagnosis of left ventricular hypertrophy (thickness of the wall of interventricular septum ≥ 12mm on echocardiography or Sv1+Rv5 ≥ 35mm on electrocardiography before informed consent);
  • Diagnosis of aortic aneurysm;
  • History of aortic dissection (more than 6 months before giving informed consent);
  • Diagnosis of arteriosclerotic peripheral arterial obstruction (Fontaine classification from 2 to 4);
  • Serum creatinine: 1.2-2.5mg/dL (male); 1.0-2.5mg/dL (female);
  • Proteinuria: ≥ +1 (or ≥ 0.3g/g･Cr. estimated from 24-hour urine collection or random urinary protein corrected by urine creatinine).

You may not qualify if:

  • Secondary hypertension or malignant hypertension
  • Heart failure (NYHA functional classification III or IV)
  • Required treatment for malignant tumor
  • Serious liver or renal dysfunction (serum creatinine \> 2.5mg/dL or with dialysis treatment)
  • Not appropriate for change to the test drugs from current therapy for hypertension or coronary diseases (i.e. calcium channel blockers, β-blockers, thiazide diuretics, etc.)
  • History of serious adverse drug reactions to angiotensin II receptor blockers or calcium channel blockers
  • Patients with other serious reasons (i.e. illness, significant abnormalities, etc.) that investigators judge inappropriate for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Cardiovascular Medicine Graduate School of Medical Science Kumamoto University

1-1-1 Honjyo, Kumamoto-City, Kumamoto, 860-8556, Japan

Location

OSCAR-Study Data Center

ShinjukuParkTower30FN, 3-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 163-1030, Japan

Location

Related Publications (6)

  • Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.

    PMID: 36975019DERIVED

  • Kim-Mitsuyama S, Ogawa H, Matsui K, Jinnouchi T, Jinnouchi H, Arakawa K; OSCAR Study Group. Differential effectiveness of ARB plus CCB therapy and high-dose ARB therapy in high-risk elderly hypertensive patients: subanalysis of the OSCAR study. Hypertens Res. 2015 Mar;38(3):199-207. doi: 10.1038/hr.2014.164. Epub 2014 Dec 4.

    PMID: 25471234DERIVED

  • Matsui K, Kim-Mitsuyama S, Ogawa H, Jinnouchi T, Jinnouchi H, Arakawa K; OlmeSartan Calcium Antagonists Randomized (OSCAR) Study Group. Sex differences in response to angiotensin II receptor blocker-based therapy in elderly, high-risk, hypertensive Japanese patients: a subanalysis of the OSCAR study. Hypertens Res. 2014 Jun;37(6):526-32. doi: 10.1038/hr.2014.23. Epub 2014 Mar 6.

    PMID: 24599010DERIVED

  • Kim-Mitsuyama S, Ogawa H, Matsui K, Jinnouchi T, Jinnouchi H, Arakawa K. 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. Kidney Int. 2013 Jan;83(1):167-76. doi: 10.1038/ki.2012.326. Epub 2012 Oct 10.

    PMID: 23051740DERIVED

  • Ogawa H, Kim-Mitsuyama S, Matsui K, Jinnouchi T, Jinnouchi H, Arakawa K; OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study Group. Angiotensin II receptor blocker-based therapy in Japanese elderly, high-risk, hypertensive patients. Am J Med. 2012 Oct;125(10):981-90. doi: 10.1016/j.amjmed.2011.12.010. Epub 2012 Apr 14.

    PMID: 22503610DERIVED

  • Ogawa H, Kim-Mitsuyama S, Jinnouchi T, Matsui K, Arakawa K. 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 calcium channel blocker in Japanese elderly high-risk hypertensive patients (ClinicalTrials. gov no. NCT00134160). Hypertens Res. 2009 Jul;32(7):575-80. doi: 10.1038/hr.2009.60. Epub 2009 May 15.

    PMID: 19444280DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular DiseasesDiabetes Mellitus, Type 2

Interventions

Olmesartan MedoxomilCalcium Channel BlockersAmlodipineazelnidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic UsesDihydropyridinesPyridines

Study Officials

  • Kikuo Arakawa, MD

    Emeritus Professor Fukuoka University, Fukuoka, Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

August 1, 2005

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 5, 2010

Record last verified: 2010-10

Locations

JP(2)