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

Stopped early · Phase 3

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00170950

Run by

Novartis

People needed

11506

Starts

2003-10-01

Expected to finish

2008-05-01

Last updated by the study team

2023-10-24

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States
• sites in Denmark — Denmark, Denmark
• sites in Finland — Finland, Finland
• sites in Norway — Norway, Norway
• sites in Sweden — Sweden, Sweden

Full record on ClinicalTrials.gov

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