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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014