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HypertensionPhase 4NCT00134160

OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study

A Phase 4 study testing Olmesartan medoxomil and Calcium channel blockers (amlodipine, azelnidipine) in people with Hypertension and Cardiovascular Diseases, run by OSCAR Study at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 to 84 years
Conditions the study is for
Hypertension, Cardiovascular Diseases
What is being tested?
Olmesartan medoxomil and Calcium channel blockers (amlodipine, azelnidipine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
2 sitesJapan
Study dates
Aug 2005to May 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 84 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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);
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  • 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).

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Department of Cardiovascular Medicine Graduate School of Medical Science Kumamoto University

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

  • OSCAR-Study Data Center

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

Other trials in Japan

About this study

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

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.

Read the 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 20mg/day 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 40mg/day in the high-dose ARB monotherapy group, or olmesartan medoxomil 20mg/day 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.

Being tested
Olmesartan medoxomil, Calcium channel blockers (amlodipine, azelnidipine)
Keywords
Aged, Hypertension, Cardiovascular Diseases, Angiotensin II Type 1 Receptor Blockers, Calcium Channel Blockers, Combination Drug Therapy, Diabetes Mellitus Type 2
Medical subject headings
Hypertension, Cardiovascular Diseases, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olmesartan medoxomilDrug

    Olmesartan medoxomil 40mg/Day

  • Calcium channel blockers (amlodipine, azelnidipine)Drug

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

Study groups in NCT00134160
Study groupRoleWhat they receive
1Active comparatorHigh-dose ARB monotherapy
Receives: Drug: Olmesartan medoxomil
2Active comparatorCombination therapy of ARB with Calcium Channel Blocker
Receives: Drug: Calcium channel blockers (amlodipine, azelnidipine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 36 Months

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

    Measured: 36 Months

  3. Heart failure

    Measured: 36 Months

  4. Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases)

    Measured: 36 Months

  5. Diabetic complications (nephropathy, retinopathy and neuropathy)

    Measured: 36 Months

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

    Measured: 36 Months

  7. All cause mortality

    Measured: 36 Months

Secondary outcomes (3)

  1. Development of each cardiovascular event

    Measured: 36 Months

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

    Measured: 36 Months

  3. Serious adverse events other than primary outcome events

    Measured: 36 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00134160
Sponsor's protocol ID
15-April-2005
Status last verified
Oct 2010
First submitted
22 Aug 2005
Last updated
5 Oct 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36975019

  • 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.

    PubMed 25471234

  • 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.

    PubMed 24599010

  • 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.

    PubMed 23051740

  • 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.

    PubMed 22503610

  • 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.

    PubMed 19444280

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olmesartan medoxomil and Calcium channel blockers (amlodipine, azelnidipine) in people with Hypertension and Cardiovascular Diseases, run by OSCAR Study at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00134160, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2010.

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