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The Confirmatory Olmesartan Plaque Regression Study

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension; Carotid Plaque

Intervention: Atenolol (Drug); olmesartan medoxomil (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Daiichi Sankyo Europe, GmbH

Official(s) and/or principal investigator(s):
Klaus O Stumpe, MD, Principal Investigator, Affiliation: Centre of Preventative Medicine

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in carotid plaque volume

Secondary outcome:

Change in plaque volume after 52 weeks, olmesartan versus atenolol

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

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

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

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

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

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

Change in PV from baseline 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.

Change in PV from baseline 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.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Sesto Fiorentino 50019, Italy
Additional Information

Starting date: May 2010
Last updated: March 30, 2012

Page last updated: August 23, 2015

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