The Confirmatory Olmesartan Plaque Regression Study (CONFIRM)

This study has been terminated.
(Low recruitment)
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH )
ClinicalTrials.gov Identifier:
NCT01132768
First received: May 26, 2010
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Essential Hypertension
Carotid Plaque
Drug: Atenolol
Drug: olmesartan medoxomil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Angiotensin-Receptor Blockade With Olmesartan on Carotid Atherosclerosis in Patients With Hypertension: The Confirmatory Olmesartan Plaque Regression Study

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change in carotid plaque volume [ Time Frame: 78 weeks (week 78 - week 0) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Change in plaque volume after 52 weeks, olmesartan versus atenolol [ Time Frame: 52 weeks (week 52 - week 0) ] [ Designated as safety issue: No ]
    change in plaque volume PV from baseline (week 0) to Week 52 on olmesartan therapy versus atenolol therapy

  • Percentage changes of PV from baseline to Week 52 for olmesartan versus atenolol. [ Time Frame: 52 weeks (week 52-week 0) ] [ Designated as safety issue: No ]
    Determine the percentage changes of PV from baseline (week 0) to Week 52 for olmesartan versus atenolol.

  • Percentage changes of PV from baseline to Week 78 for olmesartan versus atenolol. [ Time Frame: 78 weeks (week 78 - week 0) ] [ Designated as safety issue: No ]
    Determine the percentage changes of PV from baseline (Week 0) to Week 78 for olmesartan versus atenolol.

  • Change in seated diastolic blood pressure (SeDBP) from baseline to Week 52 for olmesartan versus atenolol. [ Time Frame: 52 weeks (week 52 - week 0) ] [ Designated as safety issue: No ]
    Determine the change in seated diastolic blood pressure (SeDBP) from baseline (week 0) to Week 52 for olmesartan versus atenolol.

  • Change in seated diastolic blood pressure (SeDBP) from baseline to Week 78 for olmesartan versus atenolol. [ Time Frame: 78 weeks (week 78 - week 0) ] [ Designated as safety issue: No ]
    Determine the change in seated diastolic blood pressure (SeDBP) from baseline (week 0) to Week 78 for olmesartan versus atenolol.

  • Change in seated systolic blood pressure (SeSBP) from baseline to Week 52 for olmesartan versus atenolol. [ Time Frame: 52 weeks (week 52 - week 0) ] [ Designated as safety issue: No ]
    Determine the change in seated systolic blood pressure (SeSBP) from baseline (week 0)to Week 52 for olmesartan versus atenolol.

  • Change in seated systolic blood pressure (SeSBP) from baseline to Week 78 for olmesartan versus atenolol. [ Time Frame: 78 weeks (week 78 - week 0) ] [ Designated as safety issue: No ]
    Determine the change in seated systolic blood pressure (SeSBP) from baseline (week 0) to Week 78 for olmesartan versus atenolol.

  • Change in PV from baseline to Week 52 after adjustments for changes in SeDBP from baseline. [ Time Frame: 52 weeks (week 52 - week 0) ] [ Designated as safety issue: No ]
    Determine the change in PV from baseline (week 0) to Week 52 after adjustments for changes in SeDBP from baseline.

  • Change in PV from baseline to Week 78 after adjustments for changes in SeDBP from baseline. [ Time Frame: 78 weeks (Week 78 - week 0) ] [ Designated as safety issue: No ]
    Determine the change in PV from baseline (week 0) to Week 78 after adjustments for changes in SeDBP from baseline.

  • Change in PV from baseline to Week 52 after adjustments for changes in SeSBP from baseline. [ Time Frame: 52 weeks (week 52 - week 0) ] [ Designated as safety issue: No ]
    Determine the change in PV from baseline (week 0) to Week 52 after adjustments for changes in SeSBP from baseline.

  • Change in PV from baseline to Week 78 after adjustments for changes in SeSBP from baseline. [ Time Frame: 78 weeks (Week 78- week 0) ] [ Designated as safety issue: No ]
    Determine the change in PV from baseline (week 0) to Week 78 after adjustments for changes in SeSBP from baseline.


Enrollment: 114
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atenolol
Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily.
Drug: Atenolol
Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily
Experimental: Olmesartan medoxomil
Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily.
Drug: olmesartan medoxomil
Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132768

Locations
Italy
Sesto Fiorentino, Italy, 50019
Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH
Investigators
Principal Investigator: Klaus O Stumpe, MD Centre of Preventative Medicine
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH )
ClinicalTrials.gov Identifier: NCT01132768     History of Changes
Other Study ID Numbers: DSE-OLM-01-09
Study First Received: May 26, 2010
Last Updated: March 30, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency

Additional relevant MeSH terms:
Hypertension
Carotid Artery Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atenolol
Olmesartan medoxomil
Olmesartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014