The Confirmatory Olmesartan Plaque Regression Study (CONFIRM)

Daiichi Sankyo

Status and phase

Terminated

Phase 4

Conditions

Essential Hypertension

Carotid Plaque

Treatments

Drug: Atenolol

Drug: olmesartan medoxomil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01132768

DSE-OLM-01-09

Details and patient eligibility

About

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

Enrollment

114 patients

Sex

All

Ages

40+ years old

Volunteers

No 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.