Clinical trial NCT00170950
Conditions: Hypertension
Keywords: cardiovascular morbidity cardiovascular mortality benazepril amlodipine high risk population
Sponsor: Novartis
Start date: 2003-10-01; Completion date: 2008-05-01
Enrollment: 11506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 population.

Detailed description:

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1 intervention 2: Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2 intervention 3: Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter intervention 4: Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1 intervention 5: Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2 intervention 6: Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter
Intervention descriptions: intervention 1: Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily. intervention 2: Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily. intervention 3: 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 4: Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily. intervention 5: Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily. intervention 6: 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.

Protocol documents: