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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

11506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Benazepril/amlodipine

Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a forced titration to Dose Level 2 for a subsequent 4 week period. Thereafter, patients were titrated as needed to Dose Level 3 to achieve a target blood pressure of \< 140/\< 90 mm Hg. For patients with diabetes or chronic kidney disease, investigators were encouraged to use a target blood pressure of 130/80 mm Hg.

Group Type EXPERIMENTAL

Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1

Intervention Type DRUG

Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily.

Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2

Intervention Type DRUG

Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily.

Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter

Intervention Type DRUG

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/hydrochlorothiazide

Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a forced titration to Dose Level 2 for a subsequent 4 week period. Thereafter, patients were titrated as needed to Dose Level 3 to achieve a target blood pressure of \< 140/\< 90 mm Hg. For patients with diabetes or chronic kidney disease, investigators were encouraged to use a target blood pressure of 130/80 mm Hg.

Group Type ACTIVE_COMPARATOR

Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2

Intervention Type DRUG

Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily.

Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter

Intervention Type DRUG

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.

Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1

Intervention Type DRUG

Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily.

Interventions

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Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2

Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily.

Intervention Type DRUG

Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter

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 Type DRUG

Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1

Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily.

Intervention Type DRUG

Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2

Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily.

Intervention Type DRUG

Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter

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.

Intervention Type DRUG

Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1

Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No