Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Amlodipine; Antihypertensive Agents; Benazepril; Hydrochlorothiazide

Criteria

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.