Status:
TERMINATED
Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
11506 Patients enrolled
Trial Details
Trial ID
NCT00170950
Start Date
October 1 2003
End Date
May 1 2008
Last Update
October 24 2023
Active Locations (5)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
2
sites in Denmark
Denmark, Denmark
3
sites in Finland
Finland, Finland
4
sites in Norway
Norway, Norway