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The Confirmatory Olmesartan Plaque Regression Study (CONFIRM)

Primary Purpose

Essential Hypertension, Carotid Plaque

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Atenolol
olmesartan medoxomil
Sponsored by
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Atenolol

Olmesartan medoxomil

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 26, 2010
Last Updated
December 20, 2018
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
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1. Study Identification

Unique Protocol Identification Number
NCT01132768
Brief Title
The Confirmatory Olmesartan Plaque Regression Study
Acronym
CONFIRM
Official Title
Effects of Angiotensin-Receptor Blockade With Olmesartan on Carotid Atherosclerosis in Patients With Hypertension: The Confirmatory Olmesartan Plaque Regression Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Carotid Plaque

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atenolol
Arm Type
Active Comparator
Arm Description
Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily.
Arm Title
Olmesartan medoxomil
Arm Type
Experimental
Arm Description
Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily.
Intervention Type
Drug
Intervention Name(s)
Atenolol
Intervention Description
Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily
Primary Outcome Measure Information:
Title
Change in carotid plaque volume
Description
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).
Time Frame
78 weeks (week 78 - week 0)
Secondary Outcome Measure Information:
Title
Change in plaque volume after 52 weeks, olmesartan versus atenolol
Description
change in plaque volume PV from baseline (week 0) to Week 52 on olmesartan therapy versus atenolol therapy
Time Frame
52 weeks (week 52 - week 0)
Title
Percentage changes of PV from baseline to Week 52 for olmesartan versus atenolol.
Description
Determine the percentage changes of PV from baseline (week 0) to Week 52 for olmesartan versus atenolol.
Time Frame
52 weeks (week 52-week 0)
Title
Percentage changes of PV from baseline to Week 78 for olmesartan versus atenolol.
Description
Determine the percentage changes of PV from baseline (Week 0) to Week 78 for olmesartan versus atenolol.
Time Frame
78 weeks (week 78 - week 0)
Title
Change in seated diastolic blood pressure (SeDBP) from baseline to Week 52 for olmesartan versus atenolol.
Description
Determine the change in seated diastolic blood pressure (SeDBP) from baseline (week 0) to Week 52 for olmesartan versus atenolol.
Time Frame
52 weeks (week 52 - week 0)
Title
Change in seated diastolic blood pressure (SeDBP) from baseline to Week 78 for olmesartan versus atenolol.
Description
Determine the change in seated diastolic blood pressure (SeDBP) from baseline (week 0) to Week 78 for olmesartan versus atenolol.
Time Frame
78 weeks (week 78 - week 0)
Title
Change in seated systolic blood pressure (SeSBP) from baseline to Week 52 for olmesartan versus atenolol.
Description
Determine the change in seated systolic blood pressure (SeSBP) from baseline (week 0)to Week 52 for olmesartan versus atenolol.
Time Frame
52 weeks (week 52 - week 0)
Title
Change in seated systolic blood pressure (SeSBP) from baseline to Week 78 for olmesartan versus atenolol.
Description
Determine the change in seated systolic blood pressure (SeSBP) from baseline (week 0) to Week 78 for olmesartan versus atenolol.
Time Frame
78 weeks (week 78 - week 0)
Title
Change in PV from baseline to Week 52 after adjustments for changes in SeDBP from baseline.
Description
Determine the change in PV from baseline (week 0) to Week 52 after adjustments for changes in SeDBP from baseline.
Time Frame
52 weeks (week 52 - week 0)
Title
Change in PV from baseline to Week 78 after adjustments for changes in SeDBP from baseline.
Description
Determine the change in PV from baseline (week 0) to Week 78 after adjustments for changes in SeDBP from baseline.
Time Frame
78 weeks (Week 78 - week 0)
Title
Change in PV from baseline to Week 52 after adjustments for changes in SeSBP from baseline.
Description
Determine the change in PV from baseline (week 0) to Week 52 after adjustments for changes in SeSBP from baseline.
Time Frame
52 weeks (week 52 - week 0)
Title
Change in PV from baseline to Week 78 after adjustments for changes in SeSBP from baseline.
Description
Determine the change in PV from baseline (week 0) to Week 78 after adjustments for changes in SeSBP from baseline.
Time Frame
78 weeks (Week 78- week 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus O Stumpe, MD
Organizational Affiliation
Centre of Preventative Medicine
Official's Role
Principal Investigator
Facility Information:
City
Sesto Fiorentino
ZIP/Postal Code
50019
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

The Confirmatory Olmesartan Plaque Regression Study

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