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

PHASE3TerminatedINTERVENTIONAL
Enrollment

11,506

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

January 31, 2008

Study Completion Date

May 31, 2008

Conditions
Hypertension
Interventions
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.

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.

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.

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.

DRUG

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.

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.

Trial Locations (5)

07936

Novartis Pharmaceuticals, East Hanover

Unknown

sites in Denmark, Denmark

sites in Finland, Finland

sites in Norway, Norway

sites in Sweden, Sweden

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY