Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1; Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2; Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter; Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1; Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2; Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter
Intervention description: Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily.; Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily.; Benazepril hydrochloride (HCl)/amlodipine besylate: 40/10 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.; Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily.; Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily.; Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/25 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Benazepril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11506.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: cardiovascular morbidity; cardiovascular mortality; benazepril; amlodipine; high risk population

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.
    

Eligibility 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.