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Essential HypertensionPhase 4CONFIRMNCT01132768

The Confirmatory Olmesartan Plaque Regression Study

A Phase 4 study testing Atenolol and olmesartan medoxomil in people with Essential Hypertension and Carotid Plaque, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Effect of olmesartan medoxomil (20-40 mg) on plaque regression in hypertensive patients with carotid atherosclerosis. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Essential Hypertension, Carotid Plaque
What is being tested?
Atenolol and olmesartan medoxomil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteItaly
Study dates
May 2010to Jun 2011
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female Caucasian outpatients aged > 40 years.
  • High BP defined as mean SeSBP/SeDBP ≥ 140/90 mmHg.
  • One or more of the following additional risk factors:
  • Smoking;
  • Dyslipidaemia (high-density lipoprotein (HDL)-cholesterol < 0.9 mmol/L or low-density lipoprotein (LDL)-cholesterol > 2.6 mmol/L, or triglycerides > 1.7 mmol/L);
  • Left ventricular hypertrophy;
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  • Cardio-cerebrovascular events > 6 months ago;
  • Presence of target organ damage.
  • Non-calcified (not marked shadowing) plaque in the CC artery, in the internal carotid artery or the carotid bulb with a PV ≥ 0.040 cm³ (≥ 40 µL) according to the measurements of EUTARC.

Who cannot join

  • Secondary or high grade hypertension including grade III hypertension (SeSBP of > 180 mmHg or SeDBP of > 105 mmHg).
  • Stroke, myocardial infarction within the previous 6 months.
  • Interventional or surgical vascular treatment within the previous 3 months.
  • Presence of significant narrowing of the aortic or bicuspid valve and severe obstruction of cardiac outflow (hypertrophic cardiomyopathy).
  • Symptomatic heart failure.
  • Diabetes.
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  • Chronic obstructive pulmonary disease (COPD) or asthma.
  • Claudication intermittens stage II b or higher.
  • Clinical evidence of severe renal disease [including renovascular occlusive disease, nephrectomy and/or renal transplant, creatinine clearance of < 30 mL/min, macroalbuminuria (> 300 mg albumin/24 hours or 300 µg albumin/mg creatinine)].
  • Treatment with angiotensin converting enzyme (ACE)-inhibitors or angiotensin-receptor blockers (ARBs) during last 3 months.
  • Start of treatment with a lipid-lowering agent or modification of dosage within last 3 months.
  • Electrocardiographic (ECG) evidence of 2nd or 3rd degree atrioventricular (AV) block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia (< 50 beats/min at rest).
  • Known intolerance to study drugs.
  • Impaired liver function tests suggesting severe liver disorder.
  • Any life threatening disease.
  • Duplex sonographically determined stenosis of the common or internal carotid artery > 75%.
  • Plaque with marked shadowing from calcification.
  • Target plaques in CC artery extending into both internal and external arteries.
  • Pregnant or lactating female subjects.
  • Female subjects of childbearing potential without adequate contraception: intra-uterine devices, hormonal contraceptives, either oral, depot, patch or injectable and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. If a female becomes pregnant during the trial, she has to be withdrawn immediately (see section 9.4).
  • Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents.
  • Subject has previously entered this study.
  • Subjects who have received ATE within 30 days prior to entering the active treatment phase.
  • Subjects who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period.
  • Subjects with history of alcohol and or drug abuse.
  • Subjects with known malabsorption syndrome.
  • Subjects who had donated or lost 450 mL or more blood during the last three months before Screening.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Study site

    Sesto Fiorentino, 50019

Other trials in Italy

About this study

Official title: Effects of Angiotensin-Receptor Blockade With Olmesartan on Carotid Atherosclerosis in Patients With Hypertension: The Confirmatory Olmesartan Plaque Regression Study

Effect of olmesartan medoxomil (20-40 mg) on plaque regression in hypertensive patients with carotid atherosclerosis.

Being tested
Atenolol, olmesartan medoxomil
Medical subject headings
Essential Hypertension

What participants receive

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

  • AtenololDrug

    Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily

  • olmesartan medoxomilDrug

    Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily

Study groups in NCT01132768
Study groupRoleWhat they receive
AtenololActive comparatorAtenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily.
Receives: Drug: Atenolol
Olmesartan medoxomilExperimentalOlmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily.
Receives: Drug: olmesartan medoxomil

What is being measured

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

  1. Change in carotid plaque volume

    change in carotid plaque volume (PV) from baseline (week 0) as assessed by 3-D ultrasonography after 78 weeks of double-blind treatment with Olmesartan (OM) 20-40 mg daily compared to Atenololo (ATE) 50-100 mg daily (week 78 - week 0).

    Measured: 78 weeks (week 78 - week 0)

Secondary outcomes (11)

  1. Change in plaque volume after 52 weeks, olmesartan versus atenolol

    change in plaque volume PV from baseline (week 0) to Week 52 on olmesartan therapy versus atenolol therapy

    Measured: 52 weeks (week 52 - week 0)

  2. Percentage changes of PV from baseline to Week 52 for olmesartan versus atenolol.

    Determine the percentage changes of PV from baseline (week 0) to Week 52 for olmesartan versus atenolol.

    Measured: 52 weeks (week 52-week 0)

  3. Percentage changes of PV from baseline to Week 78 for olmesartan versus atenolol.

    Determine the percentage changes of PV from baseline (Week 0) to Week 78 for olmesartan versus atenolol.

    Measured: 78 weeks (week 78 - week 0)

  4. Change in seated diastolic blood pressure (SeDBP) from baseline to Week 52 for olmesartan versus atenolol.

    Determine the change in seated diastolic blood pressure (SeDBP) from baseline (week 0) to Week 52 for olmesartan versus atenolol.

    Measured: 52 weeks (week 52 - week 0)

  5. Change in seated diastolic blood pressure (SeDBP) from baseline to Week 78 for olmesartan versus atenolol.

    Determine the change in seated diastolic blood pressure (SeDBP) from baseline (week 0) to Week 78 for olmesartan versus atenolol.

    Measured: 78 weeks (week 78 - week 0)

  6. Change in seated systolic blood pressure (SeSBP) from baseline to Week 52 for olmesartan versus atenolol.

    Determine the change in seated systolic blood pressure (SeSBP) from baseline (week 0)to Week 52 for olmesartan versus atenolol.

    Measured: 52 weeks (week 52 - week 0)

  7. Change in seated systolic blood pressure (SeSBP) from baseline to Week 78 for olmesartan versus atenolol.

    Determine the change in seated systolic blood pressure (SeSBP) from baseline (week 0) to Week 78 for olmesartan versus atenolol.

    Measured: 78 weeks (week 78 - week 0)

  8. Change in PV from baseline to Week 52 after adjustments for changes in SeDBP from baseline.

    Determine the change in PV from baseline (week 0) to Week 52 after adjustments for changes in SeDBP from baseline.

    Measured: 52 weeks (week 52 - week 0)

  9. Change in PV from baseline to Week 78 after adjustments for changes in SeDBP from baseline.

    Determine the change in PV from baseline (week 0) to Week 78 after adjustments for changes in SeDBP from baseline.

    Measured: 78 weeks (Week 78 - week 0)

  10. Change in PV from baseline to Week 52 after adjustments for changes in SeSBP from baseline.

    Determine the change in PV from baseline (week 0) to Week 52 after adjustments for changes in SeSBP from baseline.

    Measured: 52 weeks (week 52 - week 0)

  11. Change in PV from baseline to Week 78 after adjustments for changes in SeSBP from baseline.

    Determine the change in PV from baseline (week 0) to Week 78 after adjustments for changes in SeSBP from baseline.

    Measured: 78 weeks (Week 78- week 0)

Timeline

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

  1. First posted28 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Why it stopped: Low recruitment

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01132768
Sponsor's protocol ID
DSE-OLM-01-09
Acronym
CONFIRM
Status last verified
Mar 2012
First submitted
26 May 2010
Last updated
24 Dec 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atenolol and olmesartan medoxomil in people with Essential Hypertension and Carotid Plaque, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 1 site in Italy.

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 9 inclusion and 27 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: stopped early, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 was stopped early (reason given: Low recruitment). Results are not available in the source record.

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?

Change in carotid plaque volume (time frame: 78 weeks (week 78 - week 0)). 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 NCT01132768.

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 24 Dec 2018.

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