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

NCT00170950 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11506

Last updated 2023-10-24

Study results available
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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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-01-31
Completion
2008-05-31

Countries

  • United States
  • Denmark
  • Finland
  • Norway
  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00170950 on ClinicalTrials.gov