A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension

CCIB002I2301

A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.

2003-10-01

2008-01-01

2008-05-01

Terminated

Early phase I

11506

Inclusion Criteria: * At least 55 years of age. * Previously untreated or treated hypertension. * For patients \>= 60 years, evidence of at least one CV disease or target organ damage, or for patients 55-59 years evidence of at least two CV diseases or target organ damage from two different organ systems as defined in the protocol. Exclusion Criteria: * Allergy to any of the drugs administered in this trial. * Current angina pectoris (ie, no anginal event requiring NTG within 1 month prior to Visit 1). * Secondary hypertension. * Refractory hypertension defined as SBP \>= 180 mmHg and/or DBP \>= 110 mmHg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators. * History of symptomatic heart failure (NYHA classes II-IV) or ejection fraction \< 40%. * Myocardial infarction, coronary revascularization (CABG or PCI), unstable angina within one month of Visit 1. * Stroke or transient ischemic event (TIA) within 3 months of Visit 1. * Significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study. * Evidence of hepatic disease (AST or ALT values \>= 2 X upper limit of normal). * Impaired renal function (serum creatinine \>= 2.5 mg/dL (221 µmol/L)). * Baseline serum potassium of \> 5.2 meq/L not on potassium supplements. * History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years. * History of clinically significant auto immune disorders such as Systemic Lupus Erythematosus. * Significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy \<5 years). * Significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study. Other protocol-defined exclusion criteria applied to the study.

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2023-10-24